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, …
Navigating Controlled Correspondences to Support Generic Drug ...
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 …
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 Roundup: March 4, 2025
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 …
Product-Specific Guidances for Generic Drug Development | FDA
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.
Helpful Webinars and Other Resources for Generic Drug …
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) …
FDA’s generic drug science and research program helps ensure regulatory standards, recommendations, and decisions that impact generic drugs are supported by current scientific …
9 Things to Know About Biosimilars and Interchangeable Biosimilars
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 …
FDA approves first generic cefovecin sodium injection for treating …
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
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.