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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

2.     Review of Drug Master Files in Advance of Certain ANDA Submissions

3.     Competitive Generic Therapies

4.     Size, Shape and Other Physical Attributes of Generic Tablets and Capsules

5.     Facility Readiness: Goal Date Decisions

6.     Information Requests and Discipline Review Letters

7.     Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants

8.     Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing and Controls Information in an NDA, ANDA or BLA

9.     ANDA Submissions-Prior Approval Supplements

#fda #guidance #learning #development #recap #gdufa #cgt #pas #anda #complexgenerics #crl

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