What are generic drugs? A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, …

Mar 4, 2024 · Office of Generic Drugs 2023 Annual Report (PDF - 1 MB) In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access …

Mar 28, 2025 · This webinar is designed for generic drug developers and regulatory professionals looking to streamline their interactions with the FDA with the usage of Controlled …

May 1, 2025 · FDA’s generic drug Science and Research Program, created under the Generic Drug User Fee Amendments (GDUFA), is an essential component of FDA’s mission to protect …

Mar 4, 2025 · Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA approved the first generics of Xarelto …

Mar 26, 2025 · The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page.

FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. About 9 in 10 prescriptions filled in the U.S. are for generics.

In the United States, 9 out of 10 prescriptions are filled by generic drugs. Compared to its brand-name (or innovator) drug product, average cost of a generic drug is 80-85% less.

Similar to generic drugs, biosimilars and interchangeable biosimilars introduce more medication options for patients and may cost less because their manufacturers rely on FDA’s finding that …

Mar 21, 2025 · FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) …