FDA reform bill seen as delicate balance of speed, safety

Article Abstract:

The reform of the US Food and Drug Administration is an attempt at compromise by the US Congress to increase the speed of the approval of new drugs and new medical devices while protecting consumers. The third-party review pilot program for medical devices has been expanded to include lower risk devices and medicines for life threatening illnesses would be reviewed more quickly than before. This legislation was approved on Nov 9, 1997.

Pharmaceutical Preparation Manufacturing, Pharmaceutical preparations, Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Medical Instruments and Supplies, Medical Instruments & Equipment, Medical Equipment and Supplies Manufacturing, Product Safety-Drugs & Cosmetics, Product Safety-Medical Equip, Laws, regulations and rules, Pharmaceutical industry, Drugs, Science and technology policy, Medical equipment, Powers and duties, Medical equipment and supplies industry, Medical equipment industry, Product safety, United States. Congress

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Dr. Kessler leaving as FDA chief; strong replacement urged

Article Abstract:

Food and Drug Administration commissioner David A. Kessler has resigned, but will continue to work until a replacement has been found. Pres Clinton had asked him to remain in office, but Kessler wanted to return to private life, after having served since 1990 when he was selected by Pres Bush. Kessler was a strong voice against tobacco firms and initiated legislation to regulate the industry to protect the nation's youth.

Officials and employees, Appointments, resignations and dismissals, Kessler, David A.

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