Submit Comments by 11/28/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Summary Company Announcement Date: September 27, 2023 FDA Publish Date: September 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential cross contamination with […]

Docket Number: FDA-2010-D-0133 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors planning to conduct studies to […]

Q1. How does a person make payment to satisfy their OMUFA facility fee(s)? Persons can submit payment to fulfill their OMUFA facility fee obligations by: Accessing […]

On This Page Date: September 28, 2023 Time: 9:00 AM – 5:00 PM ET The Food and Drug Administration (FDA or Agency) is announcing a public […]

On This Page Date: October 18 – 19, 2023 Day1: Wed, Oct 18 10:00 AM – 1:30 PM ET Day2: Thu, Oct 19 10:00 AM – […]

October 18-19, 2023  About the Meeting:  The Food and Drug Administraation, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting […]

For Immediate Release: September 26, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Summary Company Announcement Date: May 06, 2020 FDA Publish Date: May 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains undeclared minoxidil Company […]