Post-Approval Changes to NDA and ANDA ppt pdf
Post-Approval Changes to NDA and ANDA ppt pdf
Holders who intend to make post-approval changes to NDA and ANDA should follow in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.
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