Archive for February 2024

Topical ophthalmic drug developers have asked the FDA for greater clarity on evaluating visible particulate matter, extractables and leachables, and petitioned the agency for more specifics on quality issues, as the comment period closed Monday on a revised guidance for such products. Source: Drug Industry Daily

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting, including four orphan drugs, one biosimilar and two generics. Source: Drug Industry Daily

During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

In a slowdown for Venatorx Pharmaceuticals, Melinta Therapeutics and the progress of new treatment for adults with complicated urinary tract infections (cUTI), the FDA issued a Complete Response Letter (CRL) for the companies’ NDA for cefepime-taniborbactam. Source: Drug Industry Daily

A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Source: Drug Industry Daily

Companies seeking approval for medical devices that contain AI are still asked to jump through the basic regulatory hoops inherent in trying to bring any new device to market — but now the FDA is increasing its expertise in AI and asking for more data. Source: Drug Industry Daily

The FDA is withdrawing its approval of Oncopeptides’ multiple myeloma drug Pepaxto (melphalan flufenamide), effectively ending a three-year tug-of-war over the controversial drug’s future. Source: Drug Industry Daily

A robust package of success stories highlights the FDA’s Office of Generic Drugs (OGD) 2023 Annual Report, with ample credit given to Congress’ reauthorization of a program ensuring safe and effective generic medicines. Source: Drug Industry Daily

Wholesale drug acquisition and distribution stakeholders say that even by November, the industry won’t be ready to comply with the Drug Supply Chain Security Act’s (DSCSA) updated security requirements. Source: Drug Industry Daily

This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Source: Drug Industry Daily