Regulatory Affairs Syndicator

HinduVioxx safety data manipulatedHindu, India - 2 hours agoBut the Food and Drug Administration Amendment Act (FDAAA) passed last year has made it compulsory for the industry to submit trial results in a publicly …

HinduVioxx safety data manipulatedHindu, India - 14 hours agoBut the Food and Drug Administration Amendment Act (FDAAA) passed last year has made it compulsory for the industry to submit trial results in a publicly …

ABC NewsFDA examines vision problems reported with Lasik surgeryCNNMoney.com - 11 hours agoNEW YORK (Associated Press) - A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer…

RTT NewsUPDATE: Genzyme 1Q Net Drops 8.2% Amid Investment ChargeCNNMoney.com - 3 hours agoGenzyme just launched Renvela in the US in March and said the company is in active discussions with the Food and Drug Administration to expand the product…

EarthtimesSlowing Drug Sales Hit GlaxoWall Street Journal - 1 hour ago… pricing pressures, rising research-and-development costs and a stricter US Food and Drug Administration stance on new drug approvals. …GlaxoSmithKline profit down 9% on co…

Court upholds 15-year term for former drug official in NE ChinaXinhua, China - 3 hours agoZhang Shusen, 63, former director of the Liaoning Provincial Food and Drug Administration, was sentenced to 15 years last October for embezzling 300000 …

Dog Flu Diet and DiseasesUCB Shares Surge on Surprise FDA Approval of Cimzia for Crohn'sBloomberg - 1 hour ago… won US Food and Drug Administration approval for a new Crohn's disease medicine that the company expected would be delayed by…

US Congress Rebukes US Agency Over Inspections of Food and Drug …Voice of America - Apr 22, 2008By Dan Robinson Members of Congress have sharply criticized the US Food and Drug Administration, saying underfunding and a failure to act aggressiv…

US Congress Rebukes US Agency Over Inspections of Food and Drug …Voice of America - Apr 22, 2008By Dan Robinson Members of Congress have sharply criticized the US Food and Drug Administration, saying underfunding and a failure to act aggressiv…

SUBJECT: THE FOOD AND DRUG ADMINISTRATION'S FOREIGN DRUG …Federal News Service (subscription), DC - 6 hours agoToday's hearing will once again explore the question of whether the Food and Drug Administration, FDA, is adequately regu…

FDA tells Aryx Therapeutics it can test schizophrenia drugBizjournals.com, NC - 14 hours agoThe Food and Drug Administration told Aryx Therapeutics Inc. it can start clinical testing of a drug aimed at schizophrenia. Fremont-based Aryx (NASD…

Pleasanton firm to sell heart pumpSan Jose Mercury News,  USA - 37 minutes ago… heart technology," said Dr. Daniel Schultz, director of the Center for Devices and Radiological Health at the US Food and Drug Administration. …Thoratec …

US watchdog critical of FDA foreign drug oversightReuters - 1 hour agoConcern about Food and Drug Administration oversight of foreign drug manufacturers has risen since the finding of a contaminant in some batches of …Cynicism and Big Tobacco Wa…

Scientific AmericanViagra online ad stops due to FDA warningXinhua, China - 6 hours agoBEIJING, April 22 (Xinhuanet) — The US Food and Drug Administration Monday warned Pfizer Inc. for not mentioning the risks of Viagra in an online …FDA s…

Congress lays out the changes it wants to ensure that FDA can and …Seattle Post Intelligencer - 1 hour agoAfter holding a dozen investigatory hearings into the actions, or, more accurately, the lack of action, by the Food and Drug Administratio…