US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.
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DOI：
10.1177/17407745211005044
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Wallach JD
中科院分区：
文献类型：
--
作者：
Skydel JJ;Zhang AD;Dhruva SS;Ross JS;Wallach JD
The US Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for the approved or other clinical indications. Therefore, we characterized FDA postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018. We conducted a cross-sectional study of all novel therapeutics, including small molecule drugs and biologics, receiving original FDA approval from 2009 to 2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of FDA postmarketing requirements and commitments for new therapeutics at original approval, including types of studies outlined, indications to be investigated, and clinical evidence to be generated. From 2009 to 2018, FDA approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements nor commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median 2 (IQR, 1–4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not change from 2009 (median 2 (IQR, 1–4)) to 2018 (median 2 (IQR, 1–3)). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. Most therapeutics are approved by FDA with at least 1 postmarketing requirement or commitment for a clinical study, which outline investigations of safety or efficacy for both approved and unapproved indications. The median number of 2 clinical studies outlined has remained relatively constant over the last decade. Given increasing emphasis by FDA on faster approval and lifecycle evaluation of therapeutics, these findings suggest that more postmarketing requirements and commitments may be necessary to address gaps in the clinical evidence available for therapeutics at approval.
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DOI：
10.1136/bmj.j1680
发表时间：
2017-05-03
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Pease AM;Krumholz HM;Downing NS;Aminawung JA;Shah ND;Ross JS
通讯作者：
Ross JS
影响因子：
4.2
作者：
Moore, Thomas J.;Furberg, Curt D.
通讯作者：
Furberg, Curt D.
影响因子：
9.3
作者：
Wallach, Joshua D.;Luxkaranayagam, Anita T.;Ross, Joseph S.
通讯作者：
Ross, Joseph S.
影响因子：
6.7
作者：
Dal Pan, G. J.
通讯作者：
Dal Pan, G. J.
影响因子：
15.8
作者：
Koch, Cora;Schleeff, Joern;Lieb, Klaus
通讯作者：
Lieb, Klaus