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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
A lack of procedures for receiving, reviewing and evaluating complaints by a formally designated unit is one of nine observations that an FDA investigator made during a Dec. 5-9, 2022, inspection of San Diego-based Integrated Orbital Implants. Read More
A lack of conclusions or follow-up in written records of investigations into unexplained discrepancies since 2020 for Duopa Intestinal Gel (levodopa-carbidopa) prompted FDA investigators to issue a Form 483 to AbbVie’s North Chicago, Ill., facility following a Jan. 23-31 inspection. Read More
A June 22 FDA warning letter to API manufacturer Chengdu KeCheng Fine Chemicals details an October 2022 conversation in which the firm’s general manager told the FDA that his company was not shipping products to the U.S. Read More
An FDA advisory committee voted 10 to 4 to recommend Ipsen Biopharmaceuticals’ palovarotene as an effective therapy for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP), which causes tendons and ligaments to be replaced by bone. Read More
The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out of the market by the high cost of implementing the EU Medical Device Regulation 745/2017 (EU MDR). Read More