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.
1. Providing Regulatory Submission in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
2. Considerations for Wavier Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
3. Bioavailability Studies Submitted in NDAs or INDs – General Considerations
4. Providing Submissions in Electronic Format – Postmarketing Safety Reports
5. FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
6. Electronic Submission of IND Safety Reports Technical Conformance Guide
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
8. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide – Appendix to the Implementation Guide – Backwards and Forwards Compatibility
9. M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes
10. Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products
11. Review of Investigational New Drug Applications (Bio-INDs)