We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Little Progress in Drug Approval.
- Authors
Kaitin, K.I.; DiCerbo, P.A.
- Abstract
The article concludes that the mean length of the U.S. Food and Drug Administration (FDA) approval process over the past decade suggests no real improvement in new drug development and review times. Between 1987 and 1989, the FDA approved 55 new drugs that could be classified as new chemical entities, just one of them a contraceptive. According to investigators who examined these approvals, this total represented a "modest decrease" from the preceding three-year period. On average, the drugs were approved after a little more than eight years of review--five in the investigational new drug application phase and three in the new drug application phase. Researchers concluded that the mean length of the approval process over the past decade suggests "no real improvement in new drug development and review times.
- Subjects
UNITED States; DRUG approval; DRUG development; UNITED States. Food &; Drug Administration; CONTRACEPTIVE drugs; DRUGS
- Publication
Family Planning Perspectives, 1991, Vol 23, Issue 4, p148
- ISSN
0014-7354
- Publication type
Article