Regulatory Affairs Syndicator

LONDON, Jan. 26 A U.S. watchdog group says Botox injections have been linked to 16 deaths, including four children. via Earth Times

Depression - the facts and the fablesGuardian Unlimited, UK - 1 hour ago… that had ever been formally registered with the Food and Drug Administration, and then went to look for the same trials in the academic literature. …

Reuters Health News SummarySan Diego Union Tribune, United States - 6 hours agoThe Food and Drug Administration said it was not advising doctors to stop prescribing Vytorin, but the agency's announcement unnerved investors and sent …

MiddleBrook Pharmaceuticals Inc.’s new time release strep throat treatment has earned federal regulatory approval, pushing the company’s shares to nearly triple in value. via Daily Record

Merck says US rejects nonprescription statin bidReuters - 2 hours agoMerck said the Food and Drug Administration indicated in a letter that it would require a revised label and additional data from the company to gain …Merck says FDA rejects Mev…

J&J recalls 130000 balloon cathetersCNNMoney.com - 11 hours agoThe Food and Drug Administration announced the recall on its Web site Friday, saying the balloons do not deflate properly, and could potentially cause heart …Johnson & Johnso…

Cephalon Provides Update on Regulatory Status of the FENTORA …CNNMoney.com - 1 hour ago25 /PRNewswire-FirstCall/ — Cephalon, Inc., today announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental New D…

PravdaMiddleBrook to raise $21 million for strep drugBizjournals.com, NC - 5 hours agoThe Germantown firm, whose strep throat treatment called Moxatag got the green light from the Food and Drug Administration on Wednesday, said it will sell …

Reason for Recall: The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting…

The Epoch Times IrelandLarger Warning Labels Sought for BotoxThe Associated Press - 8 hours agoWASHINGTON (AP) — A public interest group petitioned the Food and Drug Administration on Thursday to increase the warnings on the popular cosmetic a…

Cangene's recombinant human growth hormone approved by the US Food …Canada NewsWire (press release), Canada - 1 hour ago24 /CNW/ - Cangene today announces that the US Food and Drug Administration ("FDA") has approved Accretrop…

WFSBBusiness DigestSalt Lake Tribune, United States - 3 hours agoThe US Food and Drug Administration announced that the New Era Canning Co. in Michigan is expanding its product recall because of potential contamination to …Canned beans rec…

The Money TimesFDA to Require Suicide Studies in Drug TrialsNew York Times, United States - 9 hours agoBy GARDINER HARRIS After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Admi…

CBS NewsDrug-Coated Stents Safe, Study ConcludesWashington Post, United States - 2 hours ago… placed in heart patients in the United States are used "off-label" — for purposes not officially approved by the Food and Drug Adminis…

2nd UPDATE: FDA Panel Backs Adolor/Glaxo GI Drug On 9-6 VoteCNNMoney.com - 4 hours agoBy Jennifer Corbett Dooren WASHINGTON -(Dow Jones)- A US Food and Drug Administration panel of outside medical experts backed a proposed drug by Adolor Corp ……