The OCE PFDD Program continuously publishes on topics to advance patient-focused drug development. Recent articles are listed below: Murugappan MN, King-Kallimanis BL, Bhatnagar V, Kanapuru B, […]

Summary Company Announcement Date: September 22, 2023 FDA Publish Date: September 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Bacillus […]

For Immediate Release: May 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, […]

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

FDA is leading research to understand how images, music, and other elements of direct-to-consumer advertising affect consumer understanding and retention of the risks and benefits of […]

On This Page Date: November 9, 2023 Time: 8:00 AM – 4:45 PM ET About The meeting will be held as a hybrid event, hosted from […]

CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and ANDAs 09/21/2011 11/25/2020   Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance […]

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

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]