Since the introduction of the Prescription D r u g User Fee in 1992, the mean approval time for new drugs has decreased from 29.9 months (1992) t o 19.2 months (1995). In 1994, 22 new drugs and 1 biological were approved. In 1995, 28 drugs and 2 biologicals were approved.
U.S. drug and biologic approvals in 1996
โ Scribed by John F. Beary III; Lara E. Robillard; Gillian R. Woollett; John D. Siegfried; Thomas X. White; David A. Shriver
- Publisher
- John Wiley and Sons
- Year
- 1997
- Tongue
- English
- Weight
- 176 KB
- Volume
- 40
- Category
- Article
- ISSN
- 0272-4391
No coin nor oath required. For personal study only.
โฆ Synopsis
Since the introduction of the Prescription Drug User Fee Act of 1992, the mean approval time for new drugs has decreased from 29.9 months (1992) to 17.8 months (1996).
๐ SIMILAR VOLUMES
The Prescription Drug User Fee Act of 1992 enhanced review resources for the Food and Drug Administration (FDA). The past 3 years have seen an unprecedented approval of 122 new drugs and 28 new biologics. Information is provided on the 39 new products approved by the
The Prescription Drug User Fee Act of 1992 enhanced review resources for the Food and Drug Administration (FDA). The past two years have seen an unprecedented approval of 92 new drugs and 19 new biologics. Information is provided on the 49 new products approved by the FDA in 1997.