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 ย Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength, ย 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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