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PAREXEL Reaches Milestone In Management Of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide
PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, announced it has reached a milestone in managing oncology-based clinical trials over the last five years, which have involved over 175,000 patients in hundreds of programs across 80 countries. PAREXEL will be marking this milestone during the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 - June 2, 2009 in Orlando, Florida. PAREXEL"s hematology and oncology experts will be available during the ASCO meeting at Booth #1980 to discuss their capabilities to support the successful development of novel cancer treatments.
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Pharmaceutical Company Manager Sentenced For Off-Label Marketing
A Branchburg, NJ, woman was sentenced for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.
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Regulations Seek To Crack Down On Medical ID Theft
New regulations seek to crack down on a little known form of identity theft -- medical identity theft, according to Kaiser Health News. "Armed with as little as a stolen name, Social Security number and date of birth, an imposter can walk into a doctor"s office or hospital and receive services billed to the victim or the insurance provider. Although few statistics are available, the Federal Trade Commission reports that medical identity theft accounts for 1.3 percent to 3 percent of all identity theft crime -- about 250,000 cases each year."
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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight

The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18). Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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