[PDF] FDA panel rejects testosterone patch for -
R Moynihan - BMJ, 2004 - carlcam.co.kr
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Role of Serology in the Diagnosis of Lyme Disease -
SL Brown, SL Hansen, JJ Langone - JAMA, 1999 - Am Med Assoc
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[CITATION] Analysis of Factors for the Prediction of the Response to Xenotransplantation -
AS DAAR - Annals of the New York Academy of Sciences, 1998 - Blackwell Synergy
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RJ Smith - Science, 1978 - sciencemag.org
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[PDF] How FDA Regulation and Injury Litigation Cripple the Medical Device Industry -
CA Homsy - Policy Analysis, 2001 - cato.org
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T Derion - Biotech-Annu-Rev, 2003 - books.google.com
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Regulatory Aspects of Invasive Glucose Measurements -
S Gutman, P Bernhardt, A Pinkos, M Moxey-Mims, T … - Diabetes Technology & Therapeutics, 2002 - liebertonline.com
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SILICONE BREAST IMPLANT SAFETY: PHYSICAL, CHEMICAL, AND BIOLOGIC PROBLEMS. -
EP Goldberg - Plastic and Reconstructive Surgery, 1997 - plasreconsurg.com
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The second body parts scandal in a year has federal health officials asking if they need to strengthen their oversight of the trade in human tissues and organs.

The Food and Drug Administration said Wednesday it has formed a task force to study its regulation of the industry, including the effectiveness of new rules implemented just last year. Since then, investigators have discovered at least two companies that collected human body parts for medical use without following federal guidelines.

"The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products," said Dr. Jesse Goodman, director of the FDA center that oversees human tissue.

Earlier this month, the FDA shut down Donor Referral Services of Raleigh, N.C., saying the company had "serious deficiencies" in its processing, donor screening and record-keeping. Company owner Philip Guyett was accused of altering records to overlook cancer and drug use by some deceased donors. Guyett has denied any wrongdoing.

The closure came after Biomedical Tissue Services, a now-defunct New Jersey company, was accused of failing to gain consent to take bones, tendons, ligaments, skin and other tissue from cadavers. The company's owner and three others have pleaded not guilty to the charges against them.

Most tissue companies follow the law, the FDA said. But the regulatory agency wants to study whether it needs to step up its oversight to ensure all companies act to protect recipients of donated tissue from communicable diseases.

Improper testing or treatment of donated tissues can lead to infections like hepatitis.

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