Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (Apr 16, 2024 18:34)
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who ha...

Biosimilar Product Information (Apr 16, 2024 18:23)
This page includes a chart of the approved biosimilar and interchangeable products. The...

Drug Safety Oversight Board (Apr 16, 2024 17:16)
The DSB is composed of representatives from two FDA Centers and eight other federal gov...

FDA Roundup: April 16, 2024 (Apr 16, 2024 14:56)
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from ...

What's New Related to Drugs (Apr 16, 2024 14:55)
Want to know what's new on drugs from FDA? This page provides quick links to the l...

Drugs@FDA Data Files (Apr 16, 2024 14:46)
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationsh...

Drug Trials Snapshots (Apr 16, 2024 14:18)
Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is pa...

Powered by Feed Informer