Regulatory Affairs Syndicator

China doesn't check plants that make US drugsChicago Tribune, United States - Feb 16, 2008The disclosure by Dr. Murray Lumpkin, deputy commissioner for international programs at the US Food and Drug Administration, comes against the backd…

A heart to heart on oat benefitsLos Angeles Times, CA - 3 hours agoAnd by 1997, the cholesterol-lowering evidence for oats was so strong that the Food and Drug Administration approved the first "food-specific claim," …

A heart to heart on oat benefitsLos Angeles Times, CA - Feb 15, 2008And by 1997, the cholesterol-lowering evidence for oats was so strong that the Food and Drug Administration approved the first "food-specific claim," …FDA warns o…

FDA Approves Abbott Cholesterol Drug SimcorCNNMoney.com - 4 hours agoWASHINGTON -(Dow Jones)- The US Food and Drug Administration Friday approved an Abbott Laboratories (ABT) drug designed to lower the level of "bad" …FDA Approves Abbo…

Wall Street JournalFDA to Propose Guidelines For 'Off-Label' Drug UseWall Street Journal - 7 hours agoBy ANNA WILDE MATHEWS and AVERY JOHNSON The Food and Drug Administration is expected to propose guidelines that would explain how drug co…

UPDATE: FDA: Rotavirus Vaccine Effective, Appears SafeCNNMoney.com - 18 hours agoBy Jennifer Corbett Dooren WASHINGTON -(Dow Jones)- The US Food and Drug Administration said Friday a proposed GlaxoSmithKline PLC (GSK) vaccine appeared to …Study:…

Dendreon Soars On Survival DataForbes, NY - 1 hour agoDendreon has sharply risen and fallen on the back of Provenge, which was initially recommended for approval by a Food and Drug Administration advisory …Dendreon drug will have to wait fo…

Researcher: FDA Was Too Slow On TrasylolCBS News, NY - 19 hours ago(CBS) A renowned researcher calculates that 22000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol …FDA Inaction Le…

The Money TimesSee's Candies recalls chocolates that may contain milkDetroit Free Press, United States - 4 hours ago… bags of Semi Sweet Chocolate Chips, which could contain undeclared traces of milk, according to a news release from th…

EarthtimesPharmion, MethylGene leukemia drug granted orphan drug status by FDACNNMoney.com - 4 hours ago… hystone deacetylase inhibitor for the treatment of acute myelogenous leukemia has been granted orphan drug status by the Food and Drug Admi…

Kissei Announces New Drug Application for Silodosin has been Filed …FOXBusiness - 11 hours ago… Pharmaceutical Co., Ltd, and previously licensed-out to Watson Pharmaceuticals, Inc. (US), has been filed with US Food and Drug Administration (FDA…

Statement of Congressman John D. Dingell, Chairman Committee on …PharmaLive.com (press release), PA - 4 hours agoWASHINGTON, February 12, 2008 - Mr. Chairman, thank you for continuing to pursue the truth regarding the Food and Drug Administ…

US inquiry widened on delay in releasing data on cholesterol drugInternational Herald Tribune, France - 19 hours agoThe four letters include ones to the Food and Drug Administration chief, Dr. Andrew von Eschenbach, demanding all records abou…

Genentech Drug Meets Breast Cancer GoalHouston Chronicle, United States - 3 hours agoAvastin is currently under review by the Food and Drug Administration as a treatment for breast cancer. The results from the study, sponsored by Genentech…

Lawmakers say may hold Bush official in contemptReuters - 11 hours agoAn Energy and Commerce subcommittee voted 12-0 on January 29 to subpoena Food and Drug Administration records from Leavitt, whose department oversees the …