Abstract
A proposal for a new agency with a new set of mandates to oversee the development of valuable new drugs and the protection of public welfare
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Mathieu, M. 1990. New Drug Development: A Regulatory Overview. Parexel International Corp., Cambridge, MA.
Peck, G.E. 1979. The food and drug laws which affect drag product design, manufacture, and distribution. In Modem Pharmaceutics, G.S. Banker and C.H. Rhodes (eds). New York: Marcel Dekker, p. 735.
Spivey, R.N.L., and A.G., Trimble, 1985. New drug applications: How long to gain approval? Clinical Pharm Therap 37: 361.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Crooke, S. Comprehensive Reform of the New Drug Regulatory Process. Nat Biotechnol 13, 25–29 (1995). https://doi.org/10.1038/nbt0195-25
Issue Date:
DOI: https://doi.org/10.1038/nbt0195-25
