FDA Advisory Committees and the New Drug Approval Process

作者: Kenneth I. Kaitin , Ann Melville , Betsy Morris

DOI: 10.1002/J.1552-4604.1989.TB03249.X

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摘要: To determine the impact of FDA advisory committee review on approval time new drug applications (NDAs) approved during five-year period 1983 through 1987, we compared NDA phase lengths reviewed chemical entities (NCEs) with those that were not and examined elapsed from final recommendation for to approval. Of 95 drugs study met Center Study Drug Development's definition an NCE, 40 (42%) submitted review--mean length was 36.9 months versus 32.4 unreviewed drugs. Reviewed in neuropharmacologic division had a longer phase, while metabolic/endocrine oncology/radiopharmaceutical divisions shorter phases, than divisions. For NCEs grouped by therapeutic rating, each category phases drugs; difference largest 1-B rated The as percent total greatest (83.0% phase) 1-A (63.2%). Results indicate is associated small overall delay when regulatory fate review.

参考文章(2)
Kenneth I. Kaitin, Barbara W. Richard, Louis Lasagna, Trends in Drug Development: The 1985-86 New Drug Approvals The Journal of Clinical Pharmacology. ,vol. 27, pp. 542- 548 ,(1987) , 10.1002/J.1552-4604.1987.TB03064.X
Charles G. Smith, Past, current, and future safety and efficacy trends in the drug industry Regulatory Toxicology and Pharmacology. ,vol. 5, pp. 241- 254 ,(1985) , 10.1016/0273-2300(85)90040-6