CDER’s Office of Surveillance and Epidemiology (OSE) 2022 Annual Report showed the total number of adverse event (AE) reports rose slightly from 2.23 million in 2021 to 2.34 million, capturing…
Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions…
The FDA and the Medical Device Innovation Consortium (MDIC) are collaborating to offer funding of up to $300,000 to medical devicemakers that use advanced technologies to enhance product quality or…
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1…
The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors monitor…
Scientists have long been perceived and portrayed in film as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality is quite…
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended pulling a Novartis sickle cell disease drug from the market and approving two others to diagnose prostate cancer and…
The FDA has proposed a rule to require sponsors of all new — and already-approved — outpatient prescription drugs and blood products to create a single-page Prescription Medication Information (PMI)…
The House Energy and Commerce Committee marked up and advanced a bill last week that would improve cost transparency for pharmacy benefit managers (PBM) by requiring that hospitals provide patients…
The European Medicines Agency (EMA), along with the regulatory authorities of three member nations, is starting a one-year pilot to test the use of electronic product information (ePI) for human…