The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors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…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily
A potential cure for amyotrophic lateral sclerosis (ALS) remained elusive this week as two pharma companies shuttered trials that just barely missed the efficacy mark. Source: Drug Industry Daily
The FDA is hoping lawmakers will pass proposed legislation giving the agency regulatory authority for in vitro clinical tests (IVCT) — a new product category that includes both laboratory-developed tests…
Neuralink has succeeded in winning FDA authorization to conduct a first-in-human clinical trial of its implantable brain interface after being denied in 2022 over safety concerns. Source: Drug Industry Daily