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Tag: FDA drug approval

FDA Generic Drug Approval: Step-by-Step Process for ANDA Submission

FDA Generic Drug Approval: Step-by-Step Process for ANDA Submission

Learn the full FDA generic drug approval process through the ANDA pathway - from identifying the reference drug to bioequivalence testing and final approval. Understand requirements, timelines, common pitfalls, and how generics save billions.

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How to Understand Authorized Generics and How They Differ from Traditional Generics

How to Understand Authorized Generics and How They Differ from Traditional Generics

Learn how authorized generics are identical to brand-name drugs but sold cheaper, and how they differ from traditional generics in ingredients, pricing, and FDA approval. Know what to ask your pharmacist.

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