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.
NewsEisai wins expert panel's approval for new sedative
Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, Read more...
ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much more...
> Novartis has scooped up a bigger share of Alnylam stock. The pharma giant now owns 13.3 percent of the company. Read more...
Enzon spins off biotech ops into $150M enterprise
Enzon Pharmaceuticals has decided to spin off its biotech operations into a new company, adopting a suggestion floated by none other than Carl Icahn. Icahn has Read more...
Astellas faces new delay for Advagraf approval
Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised Read more...
FDA blisters Purdue for 'poor' OxyContin data
Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster Read more...
Battered Discovery Labs tries to reassure investors
Discovery Laboratories is signaling investors to hang on for a few weeks more. After seeing its stock price go into meltdown mode Friday on the FDA's Read more...
FDA staffers say that Eisai sedative appears safe
FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in Read more...
FDA delays Discovery Labs approval
Discovery Labs has been dealt another blow in its quest to gain approval for Surfaxin, a treatment for premature infant respiratory distress syndrome. The FDA issued an Approvable Letter yesterday, Read more...
SPOTLIGHT: FDA backpedals on inspection funding
Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would Read more...
1,300 new hires planned for FDA expansion
The FDA is hiring some 1,300 badly-needed workers to help with drug Read more...
| Press ReleasesPRESS 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... |
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