This Article Reprint (PDF) Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Archive Download to Citation Manager Reprints & Permissions Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (11) Citing Articles via Google Scholar Google Scholar Articles by Merrill, R. A. Search for Related Content PubMed PubMed Citation Articles by Merrill, R. A. Related Collections Legal/Regulatory Issues Pharmaceuticals

Health Affairs, Vol 18, Issue 2, 96-111
Copyright © 1999 by Project HOPE

Journal Article

Modernizing the FDA: an incremental revolution

The U.S. Food and Drug Administration (FDA) is responsible for protecting consumers from unsafe or ineffective drugs and medical devices. The agency's role is defined by a growing and increasingly complex set of statutes, which reflect Congress's desires, on the one hand, to prevent product hazards and, on the other, to expedite FDA review and approval of promising new medical technologies. Congress's latest attempt to calibrate regulation to achieve these goals, the 1997 Food and Drug Administration Modernization Act, endorses certain of the FDA's own innovations and changes in the agency's ways of doing business.

                      What's this?

This article has been cited by other articles:

				W. H. Maisel Medical Device Regulation: An Introduction for the Practicing Physician Ann Intern Med, February 17, 2004; 140(4): 296 - 302. [Abstract] [Full Text] [PDF]

				K. E. Lasser, P. D. Allen, S. J. Woolhandler, D. U. Himmelstein, S. M. Wolfe, and D. H. Bor Timing of New Black Box Warnings and Withdrawals for Prescription Medications JAMA, May 1, 2002; 287(17): 2215 - 2220. [Abstract] [Full Text] [PDF]