Archive for February, 2006
Genentech Granted Six-Month Priority Review for Lucentis for the Treatment of Wet Age-Related Macular Degeneration (FinanzNachrichten)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsSOUTH SAN FRANCISCO, Calif., Feb. 28 /PRNewswire-FirstCall/ — Genentech, ( Nachrichten ) Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the use of Lucentis(TM) (ranibizumab) in the treatment of neovascular wet age-related macular degeneration (AMD). As part of the BLA filing, Genentech requested and has been granted
Investors Overly Bullish On Pfizer’s Insomnia Drug (Forbes)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsMorgan Stanley reiterated an “underweight” rating on the specialty drug company.
Callisto drug works in carcinoid cancer - United Press International
Closed Published by Google Inc. February 28th, 2006 in Google FDA News, Regulatory AffairsCallisto drug works in carcinoid cancerUnited Press International - 10 hours ago… product fulfills an "unmet medical need," which could qualify it for speeded review — within six months — under the Food and Drug Administration's …
Investors Overly Bullish On Pfizer’s Insomnia Drug (Forbes)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsMorgan Stanley reiterated an “underweight” rating on the specialty drug company.
DEP Fines Geisinger $900,000 For Mammography Violations At Lock Haven
Closed Published by FDA - Topix.net February 28th, 2006 in UncategorizedHARRISBURG - ‘ The Department of Environmental Protection today said it has fined Geisinger Medical Group $900,000 for not performing required equipment testing and falsifying records at its Lock Haven clinic, …
Regulators OK Patch to Treat Depression (WJLA-TV Washington D.C.)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsWashington (AP) - Federal regulators approved the first antidepressant skin patch on Tuesday, providing a different way to administer a drug already used by Parkinson’s disease patients. The Food and Drug Administration approved the selegiline transdermal patch, agency spokeswoman Susan Cruzan said.
FDA approves first patch to treat depression (Reuters.co.uk)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsWASHINGTON (Reuters) - The first skin patch to treat major depression in adults has won final approval to be sold in the United States, the U.S. Food and Drug Administration said on Tuesday.
FDA approves first patch to treat depression (Reuters via Yahoo! Australia & NZ Health)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsWASHINGTON (Reuters) - The first skin patch to treat major depression in adults has won final approval to be sold in the United States, the U.S. Food and Drug Administration said on Tuesday.
FDA approves first patch to treat depression (Reuters via Yahoo! News)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsThe first skin patch to treat major depression in adults has won final approval to be sold in the United States, the U.S. Food and Drug Administration said on Tuesday.
First Patch to Treat Depression Approved (San Francisco Chronicle)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsFederal regulators approved the first antidepressant skin patch on Tuesday, providing a different way to administer a drug already used by Parkinson’s disease patients. The Food and Drug Administration approved the selegiline transdermal patch, agency…
Anti-depressant skin patch approved (Reg Req’d)
Closed Published by FDA - Topix.net February 28th, 2006 in UncategorizedWASHINGTON, D.C. - Federal regulators approved the first antidepressant skin patch on Tuesday, providing a different way to administer a drug already used by Parkinson’s disease patients.
Model Food Emergency Response Plan
Closed Published by US FDA/CFSAN Food & Cosmetic Announcements February 28th, 2006 in Food Safety, Regulatory AffairsMODEL FOOD EMERGENCY RESPONSE PLAN - Cooperative Effort Results in Model Template
Closed Published by Food and Drug Administration February 28th, 2006 in Regulatory AffairsThe goal of the response plan is to enhance the protection of the nation’s agricultural industry and food security through prevention, detection, response, and recovery.
MODEL FOOD EMERGENCY RESPONSE PLAN - Cooperative Effort Results in Model Template
Closed Published by Food and Drug Administration February 28th, 2006 in Regulatory AffairsThe goal of the response plan is to enhance the protection of the nation’s agricultural industry and food security through prevention, detection, response, and recovery.
Watchdog group seeks federal ban on Darvocet and related painkillers (WALB News 10)
Closed Published by Yahoo! News Search Results for Food and Drug Admin February 28th, 2006 in Yahoo FDA News, Regulatory AffairsWASHINGTON A research group says it plans to submit a petition to the Food and Drug Administration, seeking a federal ban on painkillers it says have been associated with the deaths of more than 21-hundred people between 1981 and 1999.
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