The FDA Compounding Quality Center of Excellence annual conference is open to outsourcing facilities, compounders interested in becoming outsourcing facilities, regulators and other stakeholders. Attendees engage […]

On This Page Date: August 21 – 23, 2024 Day1: Wed, Aug 21 1:00 PM – 6:00 PM ET Day2: Thu, Aug 22 9:00 AM – […]

The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the availability, accessibility, and development of […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Our first stop on our recent European trip was London. Although the jet lag on […]

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022 (FUFRA), which included the reauthorization of the Prescription Drug […]

On This Page Date: May 7 – 8, 2024 Day1: Tue, May 7 9:00 AM – 5:00 PM ET Day2: Wed, May 8 9:00 AM – […]

For Immediate Release: April 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

On This Page Date: March 7, 2024 Time: 1:00 PM – 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR The […]

Stage 1 PQ/CMC FHIR Implementation Guide on the May 2024 HL7 Ballot: The Stage 1 FHIR Implementation Guide (IG) “Pharmaceutical Quality – Chemistry, Manufacturing and Controls […]