On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle […]

[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health […]

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 […]