Docket Number: FDA-2024-D-1829 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides details about the […]

Acyclovir Update Dosage and Administration, Clinical Pharmacology, and Adverse Reactions sections of the label with information that dosing for neonatal HSV should be based on postmenstrual […]

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Recipient Name Steven D. Garner Recipient Title Owner Safari Stem Cell, LLC 2402 Marina Bay Drive, Unit […]

Delivery Method: VIA Electronic Mail Reference #: 320-24-37 Product: Drugs Recipient: Recipient Name Mr. Koos Veel Recipient Title Managing Director Aruba Aloe Balm N.V. Pitastraat 115OranjestadAruba […]

Product: Drugs Recipient: Recipient Name Patrick Inglot Recipient Title CEO Ward Smelling Salts 719 Heritage Blvd. WLethbridge AB T1K7E6Canada [email protected] Issuing Office: Center for Drug Evaluation […]

Truseltiq (infigratinib) Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other […]

For Immediate Release: May 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

Listen Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse. On […]

Listen Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information. On June […]