The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The October month has around 09 new/revised guidance under GDUFA and DCAP provisions. The links of the guidance’s are provided below for quick review and reference.
1. Formal Meetings Between FDA and ANDA Applicants of Complex Products
https://www.fda.gov/media/107626/download
2. Review of Drug Master Files in Advance of Certain ANDA Submissions
https://www.fda.gov/media/162019/download
3. Competitive Generic Therapies
https://www.fda.gov/media/136063/download
4. Size, Shape and Other Physical Attributes of Generic Tablets and Capsules
https://www.fda.gov/media/161902/download
5. Facility Readiness: Goal Date Decisions
https://www.fda.gov/media/162018/download
6. Information Requests and Discipline Review Letters
https://www.fda.gov/media/109915/download
7. Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants
https://www.fda.gov/media/108337/download
8. Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing and Controls Information in an NDA, ANDA or BLA
https://www.fda.gov/media/162263/download
9. ANDA Submissions-Prior Approval Supplements
https://www.fda.gov/media/89263/download
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