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, and ...

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) submissions …

Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.

Aug 6, 2025 · The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand name drug ...

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.

Dec 18, 2024 · The Generic Drug Cluster has become an essential forum for international regulatory collaboration, bringing together agencies from around the world.

Jun 24, 2025 · Today, FDA approved Cefovecin Sodium for Injection for the treatment of skin infections, such as abscesses + wounds caused by certain bacterial strains, in dogs

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?

Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.