OGD Issues Guidance on Post-Complete Response Letter Meetings

The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings.  As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies.  

A 3D representation of the word final hanging on a plain white background. The word is hanging from binder paper…

Final ANDA Submission Guidance Published Today

The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format”   (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents.

There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix A of the document.