Regulatory Affairs Syndicator

Sanofi- Aventis Receives Pediatric Exclusivity for Ambien and …ag-IP-news Agency, Jordan - 1 hour agoPARIS - Sanofi-aventis announced on Thursday that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Ambien (z…

LONDON (AFX) - Diagnostics company Axis-Shield PLC said it has received marketing approval from the US Food and Drug Administration for a test to measure vitamin B12 deficiency, which leads to conditions such as Alzheimer’s disease.

Children as young as 2 who suffer from arthritis can be treated with Celebrex , but to ensure the painkiller doesn’t put them at later risk for heart attacks, their health should be tracked for decades, a Food and Drug Administration advisory panel said yesterday.

Turkey's Eczacibasi May Sell Its Generic-Drug Unit, People SayBloomberg - 2 hours ago… It has asked the US Food and Drug Administration to inspect the sites. FDA approval would increase opportunities to export medicines from Turkey. …

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

Progen Industries today announced it has received notification from the U.S. FDA that the appropriate CMC procedures have been put in place to progress its anti-cancer drug PI-88 to Phase III clinical trials.
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Should terminally ill patients be allowed access to drugs not approved by the Food and Drug Administration? That is the question a panel of experts will discuss and debate at a landmark Colloquium, Whose Life Is It, Anyway?, sponsored by the Food and Drug Law Institute (FDLI), Feb. 27, 2007, in Washington, D.C. [click link for full article]

BUSINESS TRENDS: Drug firm executive shares researchCherry Hill Courier Post, NJ - 16 hours ago… for AstraZeneca. Apruzzese shared the results of a research project by his company and the US Food And Drug Administration. The …

Biopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration’s (FDA) Blood Products Advisory Committee will meet in open session on December 14, 2006 to discuss the Navy’s proposed RESUS clinical trial of Biopure’s investigational oxygen therapeutic Hemopure(R) [he [click link for full article]

By STEVE MITCHELL Novartis said toxicity concerns may delay the Food and Drug Administration’s action on Galvus for diabetes and Tekturna for hypertension, but analysts still see a positive future for the company.

By Gzedit FINALLY, the U.S. Food and Drug Administration is warning doctors and patients of the deadly potential of methadone, and has revised dosage information included with the drug. This action, although late, may save lives.

Seemingly undaunted by his failure to push through legislation in 2005 that sought to protect ” pharmacists of conscience ” (that is, pro-life pill counters) from having to fill scrips for emergency contraceptives – or by the larger defeat inherent in the U.S. Food and Drug Administration ’s decision to approve over-the-counter sales status for the EC Plan B – Rep.

Shares of Possis Medical Inc. jumped more than 9 percent Wednesday after the medical-device company received government clearance to market a catheter for its AngioJet product - used to clear blood clots - as a …
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Black Market Dispenses HIV Drugs and Risk Treatment's cost and …Public Integrity, DC - 1 hour ago… The US government's practice of funding only ARV drugs approved by the US Food and Drug Administration rather than less expensive g…