Public Webinar: Considerations for the Design and Conduct of Externally Controlled Drug and Biological Products  4/24/2023 Guidance, Regulatory Considerations A Framework for Regulatory Use of Real-World […]

The Brief Summary is a monthly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates related to OPDP. […]

For Immediate Release: July 11, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Frailty is an aging-related syndrome of cumulative physical and physiological decline, which can include symptoms such as weakness and fatigue, greater medical complications, and lower tolerance […]

Dr. Weber: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast. Today’s topic: Insights about the FDA and EMA Parallel Scientific Advice Program […]

On this page Podcast and newsletter Podcast   Transcript Dr. Sarah Ibrahim, PhD, Associate Director of Stakeholder and Global EngagementOffice of Generic Drugs | CDER | The generic […]

Submit Comments by 09/11/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Joshua Miller Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom 1510 Quail Lake Loop, Suite […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Ketan C. Mehta Recipient Title Chief Executive Officer and Founder NeilMed Pharmaceuticals Inc. 601 Aviation BlvdSanta Rosa, […]