Abstract
Survey data were used to examine the effects that various factors may have on the length of the new drug development and approval processes. These factors include the use of formal conferences between the Food and Drug Administration (FDA) and drug manufacturers. Analyses were based on the type, number, and timing of formal FDA-sponsor meetings for new chemical entities (NCEs) approved from 1987 through 1995. The practice of holding formal conferences was widely applied; 91% of the NCEs were the subject of at least one conference during development or regulatory review, and 46% of the NCEs were the subject of at least three conferences. In addition to conferences, a number of other factors conjectured to have an effect on development and approval times were examined as explanatory factors in multiple regression analyses. The regression results for the new drug application (NDA) phase (NDA submission to NDA approval) indicated that pre-NDA meetings and NDA Days were associated with shorter approval times. Other factors that were shown to be associated with shorter approval times are a priority rating by the FDA, treatment IND status, the submission of a computer-assisted NDA (CANDA) simultaneously with the paper application, and inclusion in the user fee program.
Regressions on the investigational new drug application (IND) phase (IND filing to NDA submission) showed that pre-IND meetings and end-of-Phase II conferences were associated with shorter clinical development times, while NCEs with treatment INDs and NCEs that were subject to the user fee program were associated with longer clinical development times. These results provide empirical support for the hypothesis that collaboration between the FDA and drug sponsors has generally expedited new drug development and regulatory review.
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DiMasi, J.A., Manocchia, M. Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences. Ther Innov Regul Sci 31, 771–788 (1997). https://doi.org/10.1177/009286159703100319
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DOI: https://doi.org/10.1177/009286159703100319