Antibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018.
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ABSTRACT:
SUBMITTER: Kuzucan A
PROVIDER: S-EPMC8080959 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
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Antibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018.
Kuzucan Aida A Powers John H JH Doshi Peter P
Mayo Clinic proceedings 20201201 12
Approval by the US Food and Drug Administration (FDA) of a drug for a given indication is thought to reassure clinicians, other health care providers, and patients that substantial evidence of effectiveness exists for specific indicated populations (patients and diseases). This study examines whether FDA approval of certain antibiotics should be so reassuring for all patient populations identified in the FDA-approved labels. Specifically, this study compared patient populations covered by FDA-ap ...[more]
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