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Abstract

Food and Drug Administration (FDA) review times for supplemental indications of already-approved new chemical entities (NCEs) were compared to the review times for their associated original indications. The data show that mean supplemental indication review time for NCEs that had supplemental indications approved by the FDA during 1989-1994 was 28.3 months, 3.7 months longer than the mean review time for the original indications associated with those supplemental indications. The hypothesis of a positive mean difference between a drug's supplemental and original indication review times for the period 1989-1994 can be accepted (P = .044). Mean review time for the supplemental indications approved during 1993 and 1994 was 19.2 months, compared to 23.8 months for their associated original indications. Over this period, however, the mean difference between a drug's supplemental and original indication review times did not differ from zero by a statistically significant amount. Regression analysis provided support for the hypothesis that supplemental indications that the FDA has identified as important were reviewed, other things being equal, more quickly than other approved follow-on uses. The review time distributions for important supplemental indications and for their associated original indications, though, did not differ by a statistically significant amount.

Keywords

Supplemental indication Approval time FDA Off-label use User fees

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