This week, the FDA published three medical device classifications — clinical chemistry and clinical toxicology devices, gastroenterology-urology devices and immunology and microbiology devices. The agency also published draft strategy on…

Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations…

The FDA spells out how long it expects to take to review amendments to generic drug applications in a final guidance that reflects the agency’s commitments under the Generic Drug…

After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Source: Drug…

Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that although individual diseases and conditions might affect only a small number of…

This edition of Quick Notes features the FDA approval of Renata Medical’s child-tailored Minima Growth Stent, 510(k) clearances of Embecta’s disposable insulin patch pump and ID-FISH Technology’s Lyme disease diagnostic…

A host of problems discovered through a July FDA inspection of Biocon Biologics’ Bengaluru, India facility has led to a ten observation Form 483 for the biopharmaceutical company, which produces…

The European Medicines Agency (EMA) and Europe’s Heads of Medicines Agencies (HMA) say large language models (LLMs) — a form of AI that generates text in response to prompts —…

This excerpt is from the management report titled “Risks of Social Media Communication: A Guide to FDA and FTC Enforcement,” based in part on a webinar from FDAnews, A WCG…

Glenmark Pharmaceuticals has agreed to pay $25 million to resolve its alleged liability under the False Claims Act (FCA) for conspiring to fix the price of pravastatin, the Department of…