Regulatory Affairs Syndicator

“We will continue this valuable collaboration with surgeons to help shape the emerging minimally-invasive surgery practice and develop transformational therapies for patients. The new Edwards products featured at AATS will also support this goal.”

Among the milestones marked by Edwards — which this year celebrates its 50th anniversary of partnering with clinicians to develop life-saving innovations — are: — The treatment of more than 1 million … via Rehab Management

“It could be a quick fix, in which case the company could hear back from the FDA in 60 days”

Shares of Discovery Laboratories Inc. sank 50 percent yesterday after the company was dealt another blow in its effort to gain approval for Surfaxin, a respiratory treatment for premature infants. via Philly.com

“The fact is, it’s industry’s responsibility to demonstrate the safety of their products”

COMMENT By Lyndsey Layton Washington Post Staff Writer Sunday, April 27, 2008; Page A01 Despite more than 100 published studies by government scientists and university laboratories that have raised health … via The Washington Post

“The TAXUS Liberte Stent is a major advance in stent development and raises the bar for drug-eluting stent systems”

Boston Scientific Corporation today announced that it has received approval for the sale of its TAXUS Liberte paclitaxel-eluting coronary stent system in Canada. via Med Ad News

“I don’t think that because a ‘New England Journal of Medicine’ article is handed out by a pharmaceutical company that changes the science of the article.”

While calls for the drug industry to clean up its multibillion dollar advertising act grow louder, companies are quietly pushing for more lenient rules for pitching drugs directly to doctors. via Canadian Business Magazine

“We are excited to enter the nasal market and are confident that this new addition will continue to grow our topical allergy franchise”

The U.S. Food and Drug Administration has approved Alcon Inc.’s Patanase nasal spray for the relief of hay fever symptoms. via Dallas Business Journal

“The threat of contaminated food imports reaching our families’ plate is real, not hypothetical”

Congressmen Peter J. Roskam and Mark Kirk recently announced legislation to secure the nation’s food system and close a dangerous Food and Drug Administration oversight loophole. via Lombardian Newspaper

“These mortality analyses were neither provided to the FDA nor made public in a timely fashion”

Main Category: Clinical Trials / Drug Trials Also Included In: Alzheimer’s / Dementia Arthritis The risk-benefit profile of rofecoxib may be have been misrepresented by the study sponsor, Merck, in clinical … via MediLexicon

“The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”

FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy , the FDA said in a Federal Register notice published today. via EMaxHealth

“Direct and indirect cellular effects of aspartame on the brain”

Excessive intake of aspartame may inhibit the ability of enzymes in the brain to function normally, suggests a new review that could fan the flames of controversy over the sweetener. via Food Navigator

“Wednesday’s action shows the FDA’s commitment to protecting consumers from potentially harmful products”

Federal agents seized more than $1.3 million in illegal dietary supplements from a Brighton business that markets products to bodybuilders, authorities announced Friday. via Latest from the Ann Arbor News - MLiv…

The U.S. Food and Drug Administration has approved a new vaccine to prevent rotavirus, which causes vomiting and diarrhea in infants and children. via RedOrbit

Democrats in Congress ratcheted up their scrutiny of marketing tactics used by Amgen and Johnson and Johnson to promote their anemia drugs, suggesting they encouraged unsafe use by doctors. via WOOD-TV Grand Rapids

“We have maintained the position that our strong body of data warrants the approval of our once-daily tramadol formulation and believe that the additional analysis we conducted as proposed by the FDA confirms our position”

- Canadian drugmaker Labopharm Inc. is continuing its appeal against the U.S. Food and Drug Administration’s decision not to approve its once-daily formulation of painkiller tramadol.

The company said Tuesday is taking the issue to the next supervisory level under the regulator’s dispute resolution process. Labopharm “believes that continuing to follow the dispute resolution process is the most expeditious path to final approval,” the company stated.

Labopharm’s appeal follows additional analysis of existing data as recommended by the FDA’s Center for Drug Evaluation and Research. Read more

Main Category: Hearing / Deafness Also Included In: Regulatory Affairs / Drug Approvals Article Date: 31 Mar 2008 The U.S. Food and Drug Administration announced it is seeking a $2.2 million penalty against a … via MediLexicon