Generic Drugs: Questions & Answers | FDA
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, performance characteristics, …
Generic Drug Facts | FDA
Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.
Overview & Basics | FDA - U.S. Food and Drug Administration
Sep 16, 2025 · Generic Drug Facts Facts about generic medicines, including review standards, cost, exclusivities, and other related topics What Is the Approval Process for Generic Drugs?
Generic Drugs | FDA - U.S. Food and Drug Administration
Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.
Office of Generic Drugs 2023 Annual Report | FDA
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 …
What Is the Approval Process for Generic Drugs? | FDA
The generic drug needs to show that it is the same type of product (such as a tablet or an injectable) and uses the same time release technology (such as immediate-release, meaning …
Generic Drugs Undergo Rigorous FDA Review | FDA
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.
FY 2024 GDUFA Science and Research Report | FDA
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 …
FDA’s generic drug science and research program helps ensure regulatory standards, recommendations, and decisions that impact generic drugs are supported by current scientific …
Generic Drugs Forum (GDF) 2025 - 04/09/2025 | FDA
Dec 20, 2024 · Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generics.