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FDA: MANUFACTURERS SHOULD LABEL MEDICAL DEVICES MADE WITH DEHP

Washington DC, September 6, 2002 -- The U.S. Food and Drug Administration today issued a draft recommendation that manufacturers label medical devices made with di-2-ethylhexyl-phthalate (DEHP), a chemical linked to birth defects and other illnesses that is used to soften polyvinyl chloride (PVC) plastic. DEHP can leach from the plastic and pose a risk to some patients, particularly developing boys, FDA says.


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September 5, 2002

Contact: CDC Media Relations

404-639-3286

Press Release

CDC Continues to Track West Nile Virus in United States

The Centers for Disease Control and Prevention (CDC) continues to work with state and local health departments to help control West Nile Virus (WNV). To date there have been a total of 854 human cases of WNV infection reported to CDC from 28 states, the District of Columbia and New York City. There have been 43 fatalities reported.


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09/04/2002

Wyeth Updates Product Labels For Its Postmenopausal Hormone Therapies

Provides New Safety Information For Physicians

St. Davids, PA, September 4, 2002 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it has updated the package inserts for its postmenopausal hormone therapies Prempro(tm) (conjugated estrogens/medroxyprogesterone acetate tablets), Premphase(r) (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin(r) (conjugated estrogens tablets, USP).


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CBER issued a document to provide CBER staff policies and procedures for the resubmissions of license applications and efficacy supplements for products covered by PDUFA III Click here for the text of the document


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Combination Products Program

Combination products often involve cutting edge, novel technologies that raise not only unique scientific and technical questions, but also regulatory challenges related to where and how they should be regulated in order to ensure adequate and consistent regulatory oversight. Furthermore, the multi-Center aspect of the review and regulation of combination products presents unique challenges in review management.


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Senator Tom Daschle

SH-509 Hart Senate Office Building

Washington, DC 20510

August 27, 2002

Dear Senator Daschle:

Thank you for your commitment to providing a comprehensive, guaranteed prescription drug benefit in Medicare for the program's 40 million beneficiaries. As the Senate considers next steps on this critical issue, we, the undersigned groups, representing millions of working families, retired Americans, and people with disabilities, urge you to continue to fight for a meaningful benefit in the Medicare program.


September 4, 2002

President George W. Bush designated W. Scott Railton as Chairman of the federal Occupational Safety and Health Review Commission September 2, 2002. Mr. Railton joined the independent tribunal last month as a Commissioner after a presidential appointment. The agency adjudicates disputes between employers and employees and a separate Labor Department agency over contested safety and health inspections at American workplaces.


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