Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
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DOI: 10.1001/jamanetworkopen.2019.3410
Abstract: This cross-sectional study characterizes postapproval clinical trials sponsored by pharmaceutical companies of therapeutics approved by the US Food and Drug Administration (FDA) without postmarketing requirements or commitments. read more here.
Keywords: postapproval clinical; drug administration; clinical trials; food drug ... See more keywords
High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021
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DOI: 10.1001/jamapediatrics.2022.4131
Abstract: This cohort study examines the characteristics of high-risk therapeutic devices approved by the US Food and Drug Administration for use in children and adolescents between 2016 and 2021. read more here.
Keywords: devices approved; therapeutic devices; food drug; risk therapeutic ... See more keywords
In Vitro‐to‐In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
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DOI: 10.1111/cts.12750
Abstract: A systematic analysis of the inhibition transporter data available in New Drug Applications of drugs approved by the US Food and Drug Administration (FDA) in 2018 (N = 42) was performed. In vitro‐to‐in vivo predictions… read more here.
Keywords: drugs approved; inhibition; transporter; drug ... See more keywords