There are two regulatory pathways to bring a nonprescription drug to market in the U.S. — the drug application process and Over-the-Counter (OTC) Drug Review (OTC […]

 1999-2003 BLA information is available in the FDA Archive The therapeutic biological products include: Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics […]

FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. To facilitate these interactions and keep stakeholders as informed as possible, the […]

CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions. As they make decisions about which drug products should be prescribed […]

On This Page Date: June 6, 2024 Time: 9:30 AM – 10:40 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]

Image By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Hilary Marston, M.D., M.P.H., Chief Medical Officer  The Biologics Price Competition and Innovation […]

Docket Number: FDA-2024-D-1461 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Latest Update Clozapine Risk Evaluation and Mitigation Strategy (REMS) Advisory Committee Meeting 2024 April 25, 2024 – FDA will be hosting an in-person advisory committee meeting […]

The FDA Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts.  Contracts […]