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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
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
Ophthalmology-focused biopharma EyePoint Pharmaceuticals received an FDA Warning Letter underscoring serious GMP violations at its Watertown, Mass., facility, mostly related to a one-time injection eye drug. Read More
The FDA offers updated advice to medical device sponsors on how to use patient preference information (PPI) throughout the product lifecycle, in a new draft guidance. Read More
The FDA fired off Warning Letters to four companies — two in China and two in the U.S. — for marketing CPAP cleaning and sanitizing devices without clearance or approval. Read More
The FDA has reclassified four types of devices from the automatic class III designation to class II (special controls), and in each case the agency says the reclassification will provide a reasonable assurance of safety and effectiveness as well as enhance patients’ access to beneficial innovative devices. Read More
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Read More
The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on a quarterly basis instead of sending individual malfunction reports. Read More