Introduction | Phase 1 | Phase 2  Introduction This content provides more detailed information for the FDA PreCheck Pilot Program.  The FDA PreCheck Pilot Program seeks […]

Date: May 5 – 6, 2026 Day1: Tue, May 05 8:30 a.m. – 05:30 p.m. ET Day2: Wed, May 06 8:30 a.m. – 04:30 p.m. ET […]

We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities. Manufacturers are required to test for impurities that may be introduced […]

Frequently Asked Questions Q. Why did FDA withdraw approval of Makena and its generics? A. Makena and its generics (i.e., generic versions of Makena) are not […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Bridget M. Goddard Recipient Title Manager Pure Indulgence Aesthetics 1695 East Southlake Boulevard Suite 150Southlake, TX 76092United […]

Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to […]

Docket Number: FDA-2011-D-0611 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance document provides answers […]

[12/15/2023] Today, FDA is announcing final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health […]

[03/13/2024] EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized uses, only NDA-labeled […]