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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
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
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
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
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
Cohesive, high-performance teams are the backbone of any successful clinical research program. In this Q&A article, Carmin Gade, chief marketing officer for WCG, shares insights on developing strong teams, fostering healthy and open communication, and understanding today’s clinical research workforce. Read More
The Association for Molecular Pathology (AMP) is taking legal measures to neutralize an FDA final rule that regulates laboratory-developed tests (LDT), filing a lawsuit in the US District Court for the Southern District of Texas. Read More
A once promising surgical robotics deal with Auris Health has ended in $1 billion in damages for Johnson & Johnson, with a Delaware judge ruling that the healthcare titan failed to honor its end of a bargain involving two of Auris’ novel surgical robot systems, Monarch and iPlatform. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes features FDA approval of Neuros Medical’s electrical nerve stimulation device, clearance for Clearmind Biomedical’s neuroendoscopy system for minimally invasive neurosurgery, approval for Illumina’s cancer biomarker test with two companion diagnostics, and clearance for OxiWear’s oxygen data collection device. Read More