Regulatory Affairs Syndicator

Main Category: GastroIntestinal / Gastroenterology Also Included In: IT / Internet / E-mail Clinical Trials / Drug Trials Ethicon Endo-Surgery announced that the company has submitted a Premarket Approval … via MediLexicon

Otsuka American Pharmaceutical Inc., the U.S. subsidiary of Japanese pharmaceutical manufacturer Otsuka Pharmaceutical Co., Ltd., has agreed to pay more than $4 million to resolve allegations that it marketed … via Med Ad News

“Pre-emption is an extraordinarily powerful defense”

If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can’t sue the maker for injury if it met agency standards.

The Consumer Product Safety Commission says you can’t sue a mattress maker if your mattress bursts into flame despite meeting CPSC standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration proposals for stronger roofs. Read more

The Food and Drug Administration says recent data show patients taking HIV drugs from GlaxoSmithKline and Bristol-Myers Squibb may have increased risk of heart attack. via Gay news blog

“PEGINTRON and weight-based ribavirin was significantly more effective than flat-dosed ribavirin, especially in genotype 1 patients, and provided consistent efficacy across all weight groups”

Schering-Plough Corporation today reported that the U.S. Food and Drug Administration has approved label revisions for PEGINTRON and REBETOL combination therapy for chronic hepatitis C, recommending … via BioSpace

Posted on 03/28/2008 1:35:43 PM PDT by Responsibility2nd Ten years ago today, Viagra got the Food and Drug Administration’s stamp of approval. via Free Republic

Dole Fresh Fruit Co. on Friday joined firms recalling Honduran cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano, after they were linked to a salmonella outbreak in the U.S. and Canada.

Dozens of cases of salmonella in 16 states, including at least 14 that resulted in hospitalization, sparked the recall of the exported melons. The Food and Drug Administration blocked imports of cantaloupes from Honduras-based Agropecuaria Montelibano after the illnesses were reported. Read more

A Massachusetts company is recalling fresh cut fruit products containing cantaloupe from a Honduran company the Food and Drug Administration has linked to a multistate salmonella outbreak.

JARD said Friday its recall affects food service and retail products containing cantaloupe from Agropecuaria Montelibano and distributed in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Pennsylvania and Vermont.

The Massachusetts company said it is not aware of any illnesses associated its cantaloupe products. Read more

Health officials are warning consumers to steer clear of a liquid dietary supplement after three Tennesseans who drank it experienced hair loss and diarrhea. via WTVF Nashville

The U.S. Food and Drug Administration announced the recall of Deli Chef Tri-Bean Salad due to possible contamination. via UPI

Jan 22, 2008 - Taro Pharmaceutical Industries Ltd. reported today that its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. via Med Ad News

Bayer HealthCare Pharmaceuticals Inc. announced today, following consultation with the United States Food and Drug Administration , that it will withdraw the current liquid formulation of Leukine marketed in … via The South Mississippi Sun Herald

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

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

The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it’s sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.

Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.

A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be ‘a reasonably safe and effective’ option _ if consumers used it as directed. Read more