A new document from the Medical Device Single-Audit Program (MDSAP) outlines the program’s plan for implementing its Quality Management System (QMS) guidance on how to design, strengthen and develop quality…
The nonprofit European Association of Medical Devices Notified Bodies, known as Team NB, has published a form letter for updating devicemakers on the status of their submissions as the EU…
Federal funding of clinical studies often goes unreported — or is reported inaccurately — when drug manufacturers apply for patents, says a new report from the Government Accountability Office (GAO)…
Changes in the user fee program as a result of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) are detailed in a new FDA final guidance issued on…
Medical devicemaker Stryker has disclosed that U.S. authorities are conducting an investigation of the company for potential violation of an antibribery law covering overseas business, making this the third such…
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Source: Drug Industry…
Congress granted the FDA new authority under the Food and Drug Omnibus Reform Act of 2022 to ban a medical device for one or more intended uses, but it remains…
Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and…
In a Senate hearing on reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA), FDA Commissioner Robert Califf reiterated the agency’s call for better data and more supply chain notification…
Despite more than half of treated patients developing adverse reactions, Eli Lilly will seek a traditional full approval for donanemab after topline phase 3 data showed that the antiamyloid antibody…