On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients […]

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Summary Company Announcement Date: April 22, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is tainted with […]

OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites Webinar 6/13/2024 Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice […]

On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive […]

The FDA Compounding Quality Center of Excellence annual conference is open to outsourcing facilities, compounders interested in becoming outsourcing facilities, regulators and other stakeholders. Attendees engage […]

On This Page Date: August 21 – 23, 2024 Day1: Wed, Aug 21 1:00 PM – 6:00 PM ET Day2: Thu, Aug 22 9:00 AM – […]

The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the availability, accessibility, and development of […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Our first stop on our recent European trip was London. Although the jet lag on […]