FDA

What to Do About Endocrine Disruptors? A Q&A with Linda Birnbaum
ScientificAmerican.com | 41 minutes ago
Nearly a year ago, toxicologist Linda Birnbaum was named director of the National Institute of Environmental Health Sciences and the National Toxicology Program. She sat down with Environmental Health News journalist Jane Kay in San Francisco on Wednesday to answer questions about the environmental health risks we face today.


U.S. Food and Drug Administration Approves ABILIFY (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years) [Press Release]
Business Wire | 5 hours 7 minutes ago
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFYŽ (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.


Federal bill overhauling food safety system to be taken up next year
NJ.com | 5 hours 47 minutes ago
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Great American Smokeout 2009: Which states have most smokers?
Christian Science Monitor, The | 6 hours 36 minutes ago
Biggest opportunity for Great American Smokeout 2009 is in West Virginia, where 1 in 4 residents smokes.


APhA endorses MTM provision in Senate health-reform proposal
Drug Store News | 6 hours 36 minutes ago
By Jim FrederickWASHINGTON (Nov. 20) Community pharmacy leaders are endorsing some elements of the massive health-reform package unveiled this week by Senate majority leader Harry Reid of Nevada.


Why Pharma Doesn't Twitter
BusinessWeek | 6 hours 40 minutes ago
The FDA has so far failed to craft rules clarifying how companies can participate in online discussions


E-Commerce News: Deals: EU Gives Oracle Extension to Build Sun Deal Defense
TechNewsWorld | 11 hours 17 minutes ago
The EU executive gave them an extra six working days.


Save Flexible Sending Plans lobbying FSA reform
Drug Store News | 11 hours 26 minutes ago
By Michael JohnsenWASHINGTON (Nov. 20) A lobbying group representing employers and insurance companies on Thursday issued a statement criticizing the Senate healthcare reform bill for including a provision that would discontinue coverage of over-the-counter medicines through flexible spending accounts.


Devicemakers Still Leery of Using Third-Party Inspection Program
FDAnews | 11 hours 50 minutes ago
Devicemakers have not shown much interest in the FDA’s third-party accredited persons program, but the agency isn’t giving up on the idea yet, an FDA official says.


FDA: Drugmakers Should See Shadow Factories as Warning
FDAnews | 11 hours 50 minutes ago
The FDA is warning manufacturers about the dangers of suppliers that use show-and-shadow factory arrangements, but the industry may not be getting the message, experts say.


Dendreon's potential prostate cancer treatment Provenge gets May 1 FDA review date -- South Florida Sun-Sentinel.com
Sun-Sentinel (Fort Lauderdale, Fla.) | 12 hours 57 minutes ago
SEATTLE (AP) — Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1.


Dendreon's Provenge gets FDA review date
San Francisco Chronicle | 12 hours 58 minutes ago
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POZEN Announces Start of Enrollment For PA32540 Phase 3 Program [Press Release]
Business Wire | 15 hours 27 minutes ago
POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.


FDA Extends Review of NDA for Exalgo [Press Release]
Business Wire | 16 hours 27 minutes ago
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo? (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.


Research and Markets: Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry - Now Available [Press Release]
Business Wire | 17 hours 33 minutes ago
Research and Markets (http://www.researchandmarkets.com/research/3e1fb3/analyzing_the_gene) has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry" report to their offering.





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