Abstract：
:As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.
journal_name
Urologyjournal_title
Urologyauthors
Beitz Jdoi
10.1016/s0090-4295(00)00977-8subject
Has Abstractpub_date
2001-04-01 00:00:00pages
213-5issue
4 Suppl 1eissn
0090-4295issn
1527-9995pii
S0090429500009778journal_volume
57pub_type
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