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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
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
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 FDA hit AnuMed International with a Warning Letter for marketing multiple unapproved drugs including a “homeopathic” semaglutide for weight loss. 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
Richmond, Calif.-based Berkeley Biologics failed to file BLAs for several bone matrix products distributed to medical facilities nationwide and lacked proper screening for tissue donors, among other serious lapses cited in an FDA Warning Letter. Read More
The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels of nitrosamine impurities, in a new revised guidance. Read More
Including quantitative descriptions and information about serious adverse effects in direct-to-consumer (DTC) ads for a fictional Alzheimer’s medication heightened patients’ apprehensions about the drug, a new survey in JAMA Network Open shows, suggesting regulators may wish to begin requiring ads for these medicines to prominently display this information. Read More