Archive for June 2023

While most comments on the FDA’s draft guidance on providing predetermined change plans for devices that include use of AI or machine learning (ML) offer improvements of one sort or another, one commenter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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Elli 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. Source: Drug Industry Daily

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.” Source: Drug Industry Daily

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. Source: Drug Industry Daily