A proposal for FDA reform
- 1 August 2002
- journal article
- opinion
- Published by Springer Nature in Nature Reviews Drug Discovery
- Vol. 1 (8) , 642-648
- https://doi.org/10.1038/nrd874
Abstract
Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation.Keywords
This publication has 5 references indexed in Scilit:
- Cubist highlights FDA's antibiotic resistanceNature Biotechnology, 2002
- Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspectiveClinical Pharmacology & Therapeutics, 1995
- Returns to R&D on new drug introductions in the 1980sJournal of Health Economics, 1994
- Cost of innovation in the pharmaceutical industryJournal of Health Economics, 1991
- Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: Issues of safetyClinical Pharmacology & Therapeutics, 1984