Image By: Jaqueline Corrigan-Curay, J.D., M.D., Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, J.D., Office of Compliance, CDER […]

The FDA’s CDER NextGen Portal (CDER NextGen) now includes a Drug Supply Chain Security Act (DSCSA) portal that enables the FDA and trading partners to communicate […]

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, […]

Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company […]

What is crowdsourcing? Crowdsourcing is the practice of asking the public for ideas, information, and opinions to help solve a problem in an innovative way or […]

For Immediate Release: November 21, 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: November 17, 2023 FDA Publish Date: November 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination identified as […]

Submit Comments by 02/20/2024 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 […]

Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the […]