Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-01 Product: Drugs Recipient: Recipient Name Peter Michael, M.D. Peter Michael, M.D./G+C Research Group 1401 […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Lyndon R. Leitner Recipient Title CEO Staska Pharmaceuticals, Inc. 742 […]

Through Pediatric Research Equity Act (PREA) postmarketing requirements (PMR), FDA required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Richard Blackburn Recipient Title Chief Executive Officer Azurity Pharmaceuticals, Inc. 8 Cabot RoadWoburn, MA 01801United States [email protected] […]

Product: Drugs Recipient: Nomida.biz United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.nomida.biz FROM: The United States Food and Drug […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Lee E. Jay, Jr. Recipient Title President Aerosol and Liquid Packaging, Inc. 3701-A Southwestern Blvd. […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Mark A. Proctor Recipient Title President Accupack Midwest, Inc. 1060 Meta DriveCincinnati, OH 45237United States Issuing […]

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 […]