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…
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:…
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…
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…
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…
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…
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,…
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…
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…
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…