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While most comments on the FDA’s draft guidance on providing predetermined change plans for devices that include use of AI or machine learning (ML) offer improvements of one sort or another, one commenter doesn’t believe such change plans are even needed. Read More
Deeply embedded supply chain challenges, such as “just in time” manufacturing methodology and sole sourcing to maximize profit, are key drivers of low inventories and offshoring, said Mark Abdoo, associate commissioner of FDA’s Office for Global Policy and Strategy (OGPS) in a recent speech. Read More
Certain recalled extended dwell catheters from Teleflex, and its subsidiary Arrow International, have a risk of separating while still in the blood vessel, resulting in the FDA deeming the recall Class I because of the risk of serious injury or death. Read More
Drugmakers should make use of risk-based thinking to help prevent “catastrophic failures,” said quality expert Amanda McPharland in a June 14 WCG FDAnews webinar. Read More
In observance of the Independence Day holiday, FDAnews will not be published Tuesday, July 4. The next issue will be published Wednesday, July 5. Read More
Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B. Read More
Significant moves to limit amounts of the known human carcinogen ethylene oxide (EtO), commonly used to sterilize medical devices, will adversely affect delicate supply chains, making it difficult for hospitals to access devices needed to treat cardiac ailments, diabetes and Parkinson’s disease as well as medical supplies needed for surgery. Read More
The FDA’s final guidance on developing drugs and biologics to treat chronic rhinosinusitis with nasal polyps shares considerations sponsors should make for trial design/population, safety, effectiveness, and statistical analysis. Read More
Eli Lilly announced Thursday that it will acquire the privately held biopharmaceutical company Sigilon Therapeutics with the goal of developing encapsulated cell therapies for the potential treatment of type 1 diabetes. Read More
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
Abbott’s corrective and preventive action (CAPA) activities and results have not been adequately documented, FDA investigators found during an inspection at the company’s Arecibo, Puerto Rico, location. Read More
Failure to review and submit medical device reports (MDR) within 30 days of receipt is the key observation in an FDA form 483 received by Philips North America following an Oct. 11-27, 2022, inspection of its Bothell, Wash., facility. Read More