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Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the agency. Read More
Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing drugs to treat migraine. Read More
FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More
Face-to-face FDA meetings may have a hybrid component beginning June 12, focusing on “having only core participants with a primary speaking role in person while others join virtually” to avoid overcrowding of conference rooms as FDA staff return to on-site work. Read More
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. Read More
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. Read More
The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors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. Read More
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 rows of robots doing the manual handling of materials, and lab notebooks are now electronic in massive data centers holding vast quantities of information. Today, scientific input comes from data pulled from the cloud, with algorithms fueling scientific discovery the way bunsen burners once did. Read More
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. Read More
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. Read More