Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences:

摘要: Survey data were used to examine the effects that various factors may have on length of new drug development and approval processes. These include use formal conferences between Food Drug Administration (FDA) manufacturers. Analyses based type, number, timing FDA-sponsor meetings for chemical entities (NCEs) approved from 1987 through 1995. The practice holding was widely applied; 91% NCEs subject at least one conference during or regulatory review, 46% three conferences. In addition conferences, a number other conjectured an effect times examined as explanatory in multiple regression analyses. results application (NDA) phase (NDA submission NDA approval) indicated pre-NDA Days associated with shorter times. ...