Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Norikazu Toyoda Recipient Title President and CEO Kobayashi Healthcare International, Inc. 245 Kraft Dr.Dalton, GA […]

Acetaminophen-containing products Metabolic acidosis FDA is evaluating the need for regulatory action. Certain adenosine injection (generic product) Certain amiodarone hydrochloride injection (generic product) Look alike container […]

Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. Certain product lots were associated with increased reports of false negative […]

Export Regulations and Guidance Documents The Federal Food Drug and Cosmetics Act and Code of Federal Regulations (CFR) requirements are applicable to human drug exports for […]

14th Annual Sentinel Initiative Public Workshop COVID-19; Drug Regulatory Process; Drug Development; Drug Safety No 0 6 Tip-Offs to Rip-Offs: Don’t Fall for Health Fraud Scams […]

On This Page Date: June 17 – 18, 2024 Day1: Mon, Jun 17 12:30 PM – 5:30 PM ET Day2: Tue, Jun 18 10:00 AM – […]

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, […]

ACTIONS BY MONTH Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24 Jul-24 Aug-24 Sep-24 FY-2024 Approvals 57 51 53 56 52 48       […]