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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 innovative manufacturing technologies. Comments are being sought on integrated review documentation for development of new drugs. Read More
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 rising and many moving parts threatening to put data at greater risk than ever before. Read More
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 User Fee Amendments of 2022 (GDUFA III). Read More
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. Read More
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 people, together they constitute a large patient population. Read More
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 and EU approval of AngioDynamics’ laser atherectomy system. Read More
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 biosimilars, generic drugs and APIs. Read More
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 — may be used by medicines regulators if they follow the advice in a new guiding principles document. Read More
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 Company, presentation by Kellie Combs and Joshua Oyster, partners in the Life Sciences Regulatory and Compliance practice group of the law firm Ropes & Gray. Read More
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 Justice (DOJ) announced. Read More
The Institute for Clinical and Economic Review (ICER) determined the price set by Geron for Rytelo (imetelstat) for the treatment of anemia in patients with low-to-intermediate risk myelodysplastic syndrome (MDS) “is far out of line with the modest short term benefit suggested by the clinical trials.” Read More
The FDA issued a Letter of Support to the Critical Path Institute’s Parkinson’s consortium to encourage the use of alpha-synuclein (α-syn) — a pathologic protein linked to several neurodegenerative diseases — as a biomarker to identify people at risk of developing Parkinson’s disease and related syndromes. Read More