ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on […]

Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin […]

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was signed into law.  In addition to aiding the […]

Submit Comments by 09/24/2025 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 […]

Reference #: FEI 3004737602 Product: Drugs Recipient: Recipient Name Mr. Jeremy Willard Recipient Title President & CEO LEC Custom Products, Inc. 7 Kenview BoulevardBrampton ON L6T […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jeremy Willard Recipient Title President & CEO LEC Custom Products, Inc. 7 Kenview BoulevardBrampton ON L6T […]

Docket Number: FDA-2013-D-0744 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs The Food and Drug Administration (FDA or Agency) […]

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

When FDA first approved Xeljanz (tofacitinib), we required the manufacturer, Pfizer, to conduct a randomized safety clinical trial in patients with rheumatoid arthritis (RA) who were […]