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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
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
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
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
This week, the FDA published eight medical device classifications — cardiovascular, dental (2), hematology and pathology, neurologic, ophthalmic, orthopedic and physical medicine. Final guidance was issued on nitrosamine impurities. The agency also asked for information for future guidance on model-informed drug development. Read More
This edition of Quick Notes features announcements of UCB’s divestiture of its Chinese neurology and allergy business and collaborations between Bayer and NextRNA, Flagship Pioneering and Pfizer, and Adcendo and Multitude Therapeutics. 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
This edition of Quick Notes features FDA clearances that expand the indications of a device to treat Type 2 diabetes, label changes that eliminate aspirin use for heart pump patients, use AI and robotics to treat enlarged prostates, and a new device to collect bone marrow aspirate. Read More