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…
The FDA has issued a new final guidance on assessing COVID-19-related symptoms in drug and biologics trials for outpatient prevention/treatment of the infectious disease, overriding its prior recommendations from September…
Over the past week, the FDA issued a final rule adding the Digital Health Advisory Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial…
BTS Research Completes Corrections of FDA 483 Observations From the desk of the President & CEO On July 8, 2022, U.S. Food and Drug Administration (FDA) Investigator concluded an inspection…
While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action,…