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FDA news from FierceBiotech

 

Based: Washington, DC
Budget: $2.1 billion
Comissioner: Andrew von Eschenbach

Description: The U S. FDA is the world's premier scientific, regulatory, and public health agency. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 8,000 employees in 2006. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories. The FDA also monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person.

News

Pfizer's Fablyn may be linked to more deaths

The FDA is taking a critical look at Pfizer and Ligand's Fablyn, an osteoporosis drug the companies developed together that has been submitted to the FDA. Ahead of Monday's advisory panel meeting, Read more...
Tags: Pfizer   FDA regulation   FDA   Fablyn  

Election 2008 a win-win for BIO

BIO--the industry's trade organization--isn't supporting a particular candidate in this coming election. Why? Because no matter who wins, the industry can look forward to a level of support it Read more...

FDA approval drought despite surge in apps

The long drought of FDA approvals for new molecular entities is occurring despite some big efforts by drug developers to push through new drugs. In a new study examining NME approvals for 2007, Read more...

Cardiome shares plunge on approvable letter

After riding high on the news of positive data from a recent Phase IIb trial, shares of Cardiome Pharma swiftly sank 30 percent after investors heard that the FDA's "approvable" letter for Kynapid Read more...

FDA still hush-hush on drug rejections

It happens often in drug development: a drugmaker submits an NDA, an expert panel gives the okay, everyone expects an approval--and then the FDA delivers a not-approvable letter. In fact, it's Read more...
Tags: FDA update   FDA rejection   FDA  

FDA recruits a new generation of drug regulators

Interested in a government career devoted to drug development? Check out the FDA. The agency says it will launch a new, two-year fellowship program aimed at physicians, chemists and other pros who Read more...
Tags: FDA   FDA update  

2008 FDA trends

It's never too early to identify trends, and what better place to look than the FDA? The environment at the world's premier regulatory agency can have a significant impact the U.S. as well as the Read more...
Tags: FDA update   FDA  

Elan wins $55M judgment in patent scrap

Ireland's Elan won a $55.2 million judgment against Abraxis BioScience on Friday, prevailing in its case that Abraxis' breast cancer drug Abraxane uses a technology protected by an Elan patent. Read more...

J&J psoriasis drug may carry cancer risk

Outside experts are preparing to review ustekinumab, Centocor's injectable treatment of severe psoriasis. Two Phase III studies demonstrated Read more...

BioSante Pharma exploring its strategic alternatives

BioSante Pharmaceuticals has brought in Deutsche Bank to advise the company on its "strategic alternatives." The developer has advanced LibiGel, a topical therapy for female sexual dysfunction, into Read more...

Press Releases

PRESS RELEASE: FDA Announces Steps to Improve Advisory Committee Processes

FDA Announces Steps to Improve Advisory Committee Processes The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with Read more...

PRESS RELEASE: FDA Sends Sanofi Warning Letter for Ketek Study

FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more...

PRESS RELEASE: OIG Releases Report of FDA’s Oversight of Clinical Trials

OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed WASHINGTON, Sept. 28, 2007—Weaknesses in the Food and Drug Read more...

PRESS RELEASE: FDA Clears Genetic Lab Test for Warfarin Sensitivity

FDA Clears Genetic Lab Test for Warfarin Sensitivity The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be Read more...

PRESS RELEASE: Cephalon Warns Doctors Over Pain Drug Deaths Says FDA

Cephalon Warns Doctors Over Pain Drug Deaths Says FDA FRAZER, Pa., Sept. 13 -- Cephalon, Inc. today communicated with healthcare professionals to clarify the appropriate patient selection, dosing Read more...