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Articles tagged with "FDA"

FDA’s ‘Breakthrough Drug’ Terminology Confuses the Public

Kathryn Doyle  |  

NEW YORK (Reuters Health)—What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence…

U.S. Bans Another Indian Drug Plant over Production Quality

Reuters Staff  |  

MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…

Pacira Sues FDA over Pain Drug Marketing Restrictions

Brendan Pierson  |  

NEW YORK (Reuters)—Pacira Pharmaceuticals Inc. on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine liposome injectable suspension), for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent…

FDA Warns of Severe Joint Pain Risk with DPP-4 Diabetes Drugs

Reuters Staff  |  

(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…

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 The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…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…