Acumen Software Change Log
Template Updates
| Date | Module | Template | Change | |
| 10-May-21 | M1 UK | IMPD Full | IMPD Full Added IMPD full template | |
| 10-May-21 | M3 Templates | 3.2.R Regional Information_Placeholder.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.6 Container Closure System.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.5 Reference Standards or Materials.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.4.5 Justification of Specification.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.4.4 Batch Analyses.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.4.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.A.2 Adventitious Agents Safety Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.A.3 Excipients.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.A.1 Facilities and Equipment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.4.1 Specification.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.1 Description and Composition of the Drug Product Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.2 Pharmaceutical Development Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.3.1 Manufacturers.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.3.2 Batch Formula.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.3.3 Description of Manufacturing Process and Process Controls Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.3.4 Controls of Critical Steps and Intermediates.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.3.5 Process Validation and-or Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.1 Specifications Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.4 Justification of Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.5 Excipients of Human or Animal Origin.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.4.6 Novel Excipients.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.1 Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.3 Validation of Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.4 Batch Analyses Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.5 Characterization of Impurities.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.5.6 Justification of Specifications.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.6 Reference Standards or Materials.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.8.1 Stability Summary and Conclusion Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.8.3 Stability Data Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.7.1 Stability Summary and Conclusions Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.7.3 Stability Data Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.1 Manufacturers.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.2 Description of Manufacturing Process and Process Controls Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.3 Control of Materials Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.4 Control of Critical Steps and Intermediates Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.5 Process Validation and-or Evaluation.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.2.6 Manufacturing Process Development.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.3.1 Elucidation of Structure and Other Characteristics.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.3.2 Impurities Non-granular.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.4.2 Analytical Procedures.docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.P.7 Container Closure System [name, dosage form].docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 10-May-21 | M3 Templates | 3.2.S.1 General Information [name, manufacturer].docx | Updated guidance. Module updated to align more closely to guidance here: https://www.fda.gov/files/drugs/published/M4-Organization-of-the-Common-Technical-Document-for-the-Registration-of-Pharmaceuticals-for-Human-Use-Guidance-for-Industry.pdf | |
| 16-Nov-21 | M5 Templates | ICF - Informed Consent Form | Added | |
| 14-Sep-21 | M1 Templates | Top Line Data | Added | |
| 28-Sep-21 | M1 Templates | PLR Template | ||
| 6-Feb-23 | M1 Templates | 1.6.2 Pre-IND Meeting Background Materials | Updated guiance and structure. | |
| 29-Mar-22 | M2 Templates | 2.6.1 Introduction | Added/updated headings | |
| 1-Dec-22 | M1 Templates | 1.14.4.1 IB | Updated guidance | |
| 8-Dec-22 | M1 Templates | 1.14.4.1 IB Addendum | New addition | |
| 13-Jun-23 | M5 Templates | PADER | New addition | |
| 13-Jun-23 | M5 Templates | PSUR | New addition | |
| 3-Jul-23 | M1 Templates | DSUR | Updated to add tips | |
| 1-Aug-23 | M1 Templates | 1.14.4.1 IB Addendum | Updated footer and header | |
| 3-Nov-23 | M5 Templates | ICF - Informed Consent Form | Updated with new guidance | |
| 4-Jan-24 | M3 Templates | Facilities and Equipment.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Adventitious Agents Safety Evaluation.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Excipients.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Description and Composition of the Drug Product Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Pharmaceutical Development Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Components of the Drug Product non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Drug Product Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Manufacturing Process Development.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Container Closure System.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Microbiological Attributes.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Compatibility.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Manufactureres.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Batch Formula.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Description of Manufacturing Process and Process Controls Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Controls of Critical Steps and Intermediates.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Process Validation and-or Evaluation.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Specifications Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Analytical Procedures.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Justification of Specifications.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Excipients of Human or Animal Origin.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Novel Excipients.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Specifications.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures-Test Method.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Batch Analyses Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Characterization of Impurities.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Justification of Specifications.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | ference Standards or Materials.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | ntainer Closure System [name, dosage form].docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Container Closure System Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Stability Summary and Conclusion Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Postapproval Stability Protocol and Stability Commitment.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Stability Data Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | onal Information_Placeholder.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | thods Validation Package.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | neral Information [name, manufacturer].docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Nomenclature.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Structure.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | General Properties.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Manufacturers.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Description of Manufacturing Process and Process Controls Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Control of Materials Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Control of Critical Steps and Intermediates Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Process Validation and-or Evaluation.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Manufacturing Process Development.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Elucidation of Structure and Other Characteristics).docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Impurities Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Specification.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Analytical Procedures-Test Method.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Validation of Analytical Procedures-Test Method.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Batch Analyses .docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Justification of Specification.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Conference Standards or Materials.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Container Closure System.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Stability Summary and Conclusions Non-granular.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Post-approval Stability Protocol and Stability Commitment.docx | Updated with new guidance and tips | |
| 4-Jan-24 | M3 Templates | Stability Data Non-granular.docx | Updated with new guidance and tips | |
| 25-Mar-24 | M4 Templates | In Vitro Nonclinical Study Report | Updated with new tips | |
| 25-Mar-24 | M4 Templates | In Vivo Nonclinical Study Report | Updated with new tips | |
| 1-Apr-24 | M3 Templates | 3.2.P.3.3 | Fixed typo in heading 1 | |
| 1-Apr-24 | M3 Templates | 3.2.P.3.5 | Fixed typo in header | |
| 1-Apr-24 | M3 Templates | 3.2.P.6 | Fixed typo in header | |
| 7-Jun-24 | All Modules | All templates | Refreshed with latest Stylus version | |
| 23-Dec-24 | Module 1 CA | 1.0.7 CA General Note to Reviewer.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.0.3 Copy of Health Canada issued correspondence.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.0.5 Meeting Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.0.6 Request for Reconsideration Document.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.0.1 CA Cover Letter.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.0.4 CA Health Canada Solicited Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.4.2 CA Data Protection Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.3 Good Clinical Practices.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.4.1 Patent Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.1 Clinical Trial Site Information Form.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.3 Certification and Attestation Forms.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.2 Establishment Licensing.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.0 EU Cover Letter.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.3 EU Product Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.3.1 EU SmPC, Labelling, and Package Leaflet.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.7 Other Compliance and Site Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.7 International Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.6 Authorization for Sharing Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.5 Good Manufacturing Practices.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.4 Good Laboratory Practices.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.5.6 Good Pharmacovigilance Practices.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.9 Other Administrative Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.3 Non-Canadian Labelling.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.4 CA Investigator Brochure.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.1 CA Product Monograph.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.2.8 Post-Authorization Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.2 Inner and Outer Labels.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.8.1 Pharmacovigilance Plan.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.6 Certified Product Information Document.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.7 CA Look-alike Sound-alike Assessment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.5 Reference Product Labelling.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.8.3 Risk Communications.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.8.2 CA Risk Management Plan.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.4.3 Multidisciplinary Tabular Summaries.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.3.8.4 Other Pharmacovigilance Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.4.2 Comprehensive Summary Bioequivalence.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.6 Regional Clinical Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.5 CA Environmental Assessment Statement.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.4.1 CA PSEAT-CTA.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 CA | 1.7 Clinical Trial Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.3.4 EU Consultation with Target Patient Groups.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.4.1 EU Information About the Experts Quality.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.5.2 EU Information for Generic Hybrid Bio-similar Applications.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.4.3 EU Information About the Experts Clinical.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.5.3 EU Extended Data Market Exclusivity.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.4.2 EU Information About the Experts NonClinical.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.5.1 EU Information for Bibliographical Applications.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.5.5 EU Conditional Marketing Authorisation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.8.1 EU Pharmacovigilance System.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.6 EU Environmental Risk Assessment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.7.1 EU Information Relating to Orphan Market Exclusivity Similarity.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.7.2 EU Information Relating to Orphan Market Exclusivity.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.5.4 EU Exceptional Circumstance.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 EU | 1.9 EU Information Relating to Clinical Trials.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 MHRA | 1.0 MHRA Cover Letter and 1.2 Electronic Application Form.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.3.1 Package Leaflet.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.3.1 Intermediate Packaging.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 EU | 1.8.2 EU Risk Management Plan.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 MHRA | 1.3.1 SmPC, Labelling, and Package Leaflet.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.3.1 Summary of Product Characteristics.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.4.1 Information About the Experts Quality.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.3.4 Consultation with Target Patient Groups.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.4.3 Information About the Experts Clinical.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.4.2 Information About the Experts NonClinical.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.3.6 Braille.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.8.1 Pharmacovigilance System.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.5 Specific Requirements for Different Types of Applications.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 MHRA | 1.8.2 Risk Management Plan.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 US | 1.10.1 Request for Dispute Resolution.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 MHRA | 1.9 EU Information Relating to Clinical Trials.docx | New regional-specific M1 for MHRA | |
| 23-Dec-24 | Module 1 US | 1.10.2 Correspondence Related to Dispute Resolution.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.11.4 Multiple Module Information Amendment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.13 Request for Waiver for In Vivo Studies.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.1 Pre-IND Correspondence.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.11.1 Quality Information Amendment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.11.2 Nonclinical Information Amendment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.11.3 Clinical Information Amendment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.16 Field Alert Reports.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.2 Request to Charge for Clinical Trial.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.17 Orphan Drug Designation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.15 Request for Waiver for In Vivo Bioavailability Studies.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.14 Environmental Assessment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.14 Environmental Assessment - Categorical Exclusion.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.8 Correspondence Regarding Exemption from Informed Consent for Emergency Research.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.6 Exemption from Informed Consent for Emergency Research.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.3 Request to Charge for Expanded Access.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.4 Request for Comment_Advice.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.7 Public Disclosure Statement for Exemption from Informed Consent for Emergency Research.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.5 Request for a Waiver.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.1 Summary for Nonclinical Studies - NDA Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.1 Summary for Nonclinical Studies - IND Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.12.9 Notification of Discontinuation of Clinical Trial.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.11 Distribution Data.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.10 Foreign Marketing.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.12 Status of Postmarketing Study Commitments and Requirements .docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.15 Development Safety Update Report (DSUR).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.14 Log of Outstanding Regulatory Business - NDA Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.13 Status of Other Postmarketing Studies and Requirements.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.2 Summary for Clinical Pharmacology Information - NDA Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.2 Summary for Clinical Pharmacology Information - IND Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.14 Log of Outstanding Regulatory Business - IND Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.4 Summary of Labeling Changes.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.3 Summary of Safety Information - NDA Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.5 Summary of Manufacturing Changes - IND Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.3 Summary of Safety Information - IND Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.5 Summary of Manufacturing Changes - NDA Annual Report.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.6 Summary of Microbiological Changes.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.7 Summary of Other Significant New Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.1.3 Draft Labeling Text.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.13.8 Individual Study Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.1 Draft Labeling.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.1.2 Annotated Draft Labeling Text.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.2.2 Final Package Insert_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.1.5 Labeling History.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.2.1 Final Carton and Container Labels.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.1.4 Labeling Comprehension Studies.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.3.1 Annotated Comparison with Reference Listed Drug (RLD).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.2.3 Final Labeling Text.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.5 Foreign Labeling.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.6 Product Labeling for 2253 Submissions.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.3.3 Labeling Text for Reference Listed Drug (RLD).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.4.2 Investigational Drug Labeling.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.4.1 Investigator’s Brochure.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.14.3.2 Approved Labeling Text for Reference Listed Drug (RLD).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 General Considerations.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 Promotional Material Submitted in Fulfillment of the Postmarketing Reporting Requirements.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 Promotional Format for Electronic Submission.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 Promotional Materials Paper Hard Copy.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 Promotional Complaints.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15 Presentation Issues.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.10 Submission of Annotated References.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.1 Request for Advisory Comments on Launch Materials .docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.4 Presubmission of Non-Launch Promotional Materials for Accelerated Approval Products.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.2 Request for Advisory Comments on Non-Launch Materials.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.11 General Correspondence.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.3 Presubmission of Launch Promotional Materials for Accelerated Approval Products.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.6 Response to Untitled Letter or Warning Letter.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16 Proposed Risk Evaluation and Mitigation Strategies (REMS) With Supporting Document.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.8 Correspondence Accompanying Materials Previously Missing or Rejected.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.5 Pre-dissemination Review of Television Ads.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.9 Withdrawal Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.15.1.7 Response to Information Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.1 Final REMS_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16 Proposed Risk Evaluation and Mitigation Strategies (REMS) Without Supporting Documentation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16 Proposed Risk Evaluation and Mitigation Strategies (REMS).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16 Risk Management Plans.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.2 Draft REMS_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.3 Risk Evaluation and Mitigation Strategies (REMS) Assessment.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.17.2 Correspondence Regarding Postmarketing Requirements.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.19 Emergency Use Authorization Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.5 Risk Evlauation and Mitigation Strategies (REMS) Assessment Correspondence.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.6 Risk Evlauation and Mitigation Strategies (REMS) Modification History.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.17.1 Correspondence Regarding Postmarketing Commitments.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.16.2.4 Risk Evaluation and Mitigation Strategies (REMS) Assessment Methodology.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.2 Reviewer’s Guide.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.1.1 Change of Address.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.1.2 Change of Contact Agent.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.20 General Investigational Plan for Initial IND.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.2 Cover Letter - Original NDA Application.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.2 Cover Letter - Initial IND Application.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.4 Financial Certification and Disclosure.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.1.3 Change of Sponsor.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.3 Debarment Certification.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.1.5 Change in Ownership of an Application or Reissuance of License .docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.1.4 Transfer of Obligation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.2 Field Copy Certification.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.4.2 Statement of Right of Reference_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.6 Tropical Disease Piority Review Voucher.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.5.3 Exclusivity Claim.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.5.2 Patent Certifications.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.3.5.1 Patent Information_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.4.1 Letter of Authorization_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.2 Inactivation Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.5 Withdrawal of an Unapproved Application.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.4.4 Cross-reference to Previously Submitted Information.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.1 Withdrawal of IND.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.4 Reinstatement Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.3 Reactivation Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.6.1 Meeting Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.6.2 Pre-NDA Meeting Background Materials.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.6.1 Meeting Request_Biosimilar_Biologics.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.7 Withdrawal of approval of an application or revocation of license.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.6.2 Pre-IND Meeting Background Materials.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.5.6 Withdrawal of a Listed Drug.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.7.2 Fast Track Designation Withdrawal Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.8.1 Special Protocol Assessment Request_Clinical Study.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.6.3 Correspondence Regarding Meetings-1.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.8.2 Special Protocol Assessment_Carcinogenicity Study.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.7.1 Fast Track Designation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.7.3 Rolling Review Request.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.9.6 Other Correspondence Regarding Pediatric Exclusivity or Study Plans.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.9.4 Pediatric Study Plan.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.9.1 Request for Waiver of Pediatric Studies.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Breakthrough Therapy Designation.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.8.3 Special Protocol Assessment Request_Stability Study.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | 1.9.2 Request for Deferral of Pediatric Studies.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | IB Update Summary of Changes.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Investigator’s Brochure Addendum (1.14.4.1).docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Nonclinical Studies - NDA Annual Report_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | CMC - NDA Annual Report_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Core Data Sheet - 1.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Clinical Data - NDA Annual Report_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Request for Proprietary Name Review.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Top-Line Data Template.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Target Product Profile.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Physician’s Labeling Rule_Content.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Phase I Protocol Modifications - IND Annual Report_Placeholder.docx | Update with latest guidance and tips | |
| 23-Dec-24 | Module 1 US | Paper IND to eCTD Conversion_Cover Letter.docx | Update with latest guidance and tips | |
| 28-Feb-25 | Module 1 US | 1.13.9 General Investigational Plan.docx | Update with latest guidance and tips | |
| 19-Feb-25 | Module 1 EU | IMPD full template.docx | Refreshed template with all sections | |
| 2-May-25 | Module 4 Safety | In Vitro Pharmacology Study Report.docx | Added new writing tips | |
| 17-Dec-25 | Module 5 Efficacy | ICH M11 (CeSHaRp).docx | Update with latest guidance and tips | |
| 17-Dec-25 | Module 1 US | 1.3.1.4 Transfer of Regulatory Obligation | Update with latest guidance and tips | |
| 17-Dec-25 | Module 1 US | In Vitro Pharmacology Study Report.docx | Update with latest guidance and tips |