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 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…
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…
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)…
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…
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 —…
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…
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:…
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…