Archive for May 2023

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 patient adverse reactions along with medication error reports and product quality complaints. Source: Drug Industry Daily

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 improve the manufacturing process. Source: Drug Industry Daily

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 recommendations and FDA’s sterilization pilot. Source: Drug Industry Daily

The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors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 remote locations, such as in patients’ homes, may draw industry pushback. Source: Drug Industry Daily

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 different. Scientists are increasingly data jockeys in hoodies sitting before monitors analyzing enormous amounts of data. Modern day labs are more likely composed of sterile…

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 treat a certain form of epilepsy. Source: Drug Industry Daily

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) sheet explaining how to use the drug, its benefits and its potential risks in plain, easy-to-understand language. Source: Drug Industry Daily

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 with itemized lists for “shoppable services,” including the amount the hospital has negotiated with third-party payers for such services. Source: Drug Industry Daily

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 medicines in the EU. Source: Drug Industry Daily