US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The April month has around 11 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
FDA Updates
1. Providing Regulatory Submission in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
https://www.fda.gov/media/128163/download
2. Considerations for Wavier Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
https://www.fda.gov/media/157655/download
3. Bioavailability Studies Submitted in NDAs or INDs – General Considerations
https://www.fda.gov/media/121311/download
4. Providing Submissions in Electronic Format – Postmarketing Safety Reports
https://www.fda.gov/media/71176/download
5. FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
https://www.fda.gov/media/81904/download
6. Electronic Submission of IND Safety Reports Technical Conformance Guide
https://www.fda.gov/media/132078/download
ICH Updates:
7. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Data Elements and Message Specification; and Appendix to the Implementation Guide – Backwards and Forwards compatibility
https://www.fda.gov/media/81904/download
8. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Appendix to the Implementation Guide – Backwards and Forwards Compatibility
https://www.fda.gov/media/81904/download
9. M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes
https://www.fda.gov/media/157451/download
MaPP Updates:
10. Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products
https://www.fda.gov/media/157675/download
11. Review of Investigational New Drug Applications (Bio-INDs)