Regulatory Affairs Syndicator

US investigating generic antidepressant after complaintsInternational Herald Tribune, France - Oct 25, 2007AP TORONTO: The US Food and Drug Administration said Thursday it is investigating complaints about a generic version of the antidepress…

Dog Flu Diet and DiseasesBayer stops Canadian-led drug trial over concerns of increased …The Canadian Press, TORONTO - Drug giant Bayer Inc. confirmed Thursday that a large Canadian-led trial studying its drug Trasylol - 2 hours agoThe US F…

TopNewsSun Pharma gets US nod for Novartis' ExelonEconomic Times, India - 8 hours agoThe US Food and Drug Administration (FDA) has granted final approval for Sun Pharma's generic version of Exelon, chemically known as rivastigmine tar…

ANX-514 Reduces Hypersensitivity Reactions Without Impacting …CNNMoney.com - 1 hour agoSection 505(b)(2) of the US Food, Drug & Cosmetic Act (FDCA) allows the Food and Drug Administration (FDA) to approve a follow-on drug on the basis of dat…

FDA cites fakes results in Sanofi studyBusinessWeek - 13 hours agoThe Food and Drug Administration sent a letter to Sanofi this week outlining numerous problems with its 2002 patient study of Ketek. …FDA Says Aventis Failed To Act on Ketek Drug …

Dog Flu Diet and DiseasesProvigil drug gets new warning on labelBizjournals.com, NC - 3 hours agoThe Frazer, Pa., biotechnology company and the Food and Drug Administration announced the addition of the warning Wednesday night. …FDA adds wa…

Enews 2.0Panel Endorses Flu Vaccine in a Spray for Young ChildrenNew York Times, United States - 1 hour agoLast month, the Food and Drug Administration approved its use for children ages 2 to 5. Now, the Advisory Committee on Immunization Pr…

Stevia and the Food and Drug Administration: A Tangled TaleDiabetes Health (press release), CA - 8 hours agoStevia is a natural sweetener made from the leaves of a South American herb, Stevia rebaudiana Bertoni, commonly known as sweetleaf or…

HemscottGlaxo faces Avandia heart attack warningTimes Online, UK - 14 hours agoFears that the US Food and Drug Administration wants to impose its severest safety warning would be a blow to GlaxoSmithKline, which is expected to announce …GSK…

The REALIZE? Band is a surgically implanted device used to help a person lose weight. The REALIZE? Band consists of a silicone band, tubing, and an injection port.

Guidance for Industry, Food and Drug Administration, and Foreign …Trading Markets (press release), CA - Oct 23, 2007Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administrati…

ReutersChina food and drug official jailed for graftReuters - Oct 23, 2007Zhang Shusen, former head of the Food and Drug Administration in the northeastern province of Liaoning, embezzled funds worth 300000 yuan ($40000) and took …

Theravance receives drug approval letter from Food and Drug …CNNMoney.com - 1 hour ago… (NASDAQ:THRX) Monday said it had received an approval letter from the Food and Drug Administration for telavancin, an antibiotic for skin infections. …FD…

Theravance receives drug approval letter from Food and Drug …CNNMoney.com - Oct 22, 2007… (NASDAQ:THRX) Monday said it had received an approval letter from the Food and Drug Administration for telavancin, an antibiotic for skin infections. …

Op-Ed Contributor A Two-Cigarette SocietyNew York Times, United States - 4 hours ago… we shouldn’t waste another day. David G. Adams, a lawyer, was the director of the policy staff at the Food and Drug Administration from 1992 to 1994.