This document was downloaded and archived from on May 31, 2001.

For the most recent information on this topic, see FDA's Reinvention Initiatives Page on this Website.

See also: National Performance Review (April 1995)

Reinventing Drug and Medical Device Regulation

April 5, 1995

The Clinton Administration is committed to making government work better by reducing unnecessary regulatory burdens while maintaining the critical public health protections the American people expect and deserve. In the case of the Food and Drug Administration, reinvention of drug and medical device regulation will mean speeding up the review of these products.

The high standards of the FDA have given Americans access to drugs and medical devices that are safe and that work. In addition, FDA has worked in recent years: to make new therapies available as soon as possible, even before final approval; to accelerate the approval of life-saving drugs; and to speed up the review and approval of all drugs with additional resources from industry user fees.

The Clinton Administration is building on these high standards and efforts to speed up drug and device approval with new FDA regulatory reforms. Some of these reforms will directly speed up the review process for these products. Others will reduce unnecessary regulatory burdens on industry. All are aimed at maintaining and protecting Americans' confidence in the safety and effectiveness of the drugs they take and the medical devices they use.

FDA will reform drug and medical device regulation by:

Impact: Industry can modernize facilities and processes more easily; FDA can shift resources to more critical review needs.
BG 95-11

(Hypertext amended by clb 1999-JAN-12)

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