On This Page Date: February 27, 2025 Time: 1:00 p.m. – 3:30 p.m. ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

PQ/CMC and HL7 FHIR In order to assist in understanding the development of the PQ/CMC implementation Guide using Fast Health Interoperable Resources (FHIR) which is a […]

The Phase 1 data elements and controlled terminology have been published in the 2017 FRN. This is a high-level conceptual model covering the phase 1 groups/domains. […]

On This Page Date: March 13, 2025 Time: 1:00 p.m. – 3:00 p.m. ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. These […]

How often is the Orange Book updated? How do I obtain the Orange Book? How do I use the Electronic Orange Book to find approved generic […]

LIB4692 Update to LIB No. 4550 Quantitation of Nicotine in Tobacco Products LIB4631 Analysis of Oxytetracycline, Chloramphenicol, and Florfenicol in Lobster and Crab Tissue Using Liquid […]