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An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Articles tagged with "FDA"

FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names

Toni Clarke  |  

WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…

FDA Warns Makers of Superbug-Prone Scopes over Testing Violations

Reuters Staff  |  

(Reuters)—Manufacturers of duodenoscopes linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning letters to the companies released on Monday. The letters, sent on Aug. 12, cite Olympus Corp Pentax Medical and Fujifilm Holdings Corp with multiple violations found…

High-Risk Medical Devices Backed by Few Studies

Kathryn Doyle  |  

(Reuters Health)—Many high-risk therapeutic devices get U.S. Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk…

New Analysis Underscores Improving Pharma R&D Productivity

Ben Hirschler  |  

LONDON (Reuters)—Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014…

Some Serious Drug Side Effects Not Reported to FDA Within 15 days

Lisa Rapaport  |  

(Reuters Health)—Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths…