Tag: generic drug regulations

FDA Generic Drug Approval: Step-by-Step Process for ANDA Submission
Jan 9 2026 Charlie Hemphrey

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

Learn the step-by-step FDA generic drug approval process through the ANDA pathway, including requirements for bioequivalence, manufacturing standards, review timelines, and how generics save billions in healthcare costs.

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