Tag: FDA generic approval

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

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

Learn how the FDA approves generic drugs through the ANDA process - from bioequivalence studies to manufacturing standards and regulatory timelines. Discover what it takes to bring a generic drug to market and why it saves billions annually.

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How Governments Control Generic Drug Prices Without Direct Price Caps

How Governments Control Generic Drug Prices Without Direct Price Caps

Generic drugs make up 90% of U.S. prescriptions but only 23% of drug spending. Government policy focuses on fostering competition-not setting prices-to keep generics affordable. Here's how it works.

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