Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019

IMPORTANCE: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data to obtain supplemental approval for use for new indications. OBJECTIVE: To characterize pivotal trials supporting recent supplemental new indication approvals of drugs and bio...

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Detalhes bibliográficos
Publicado no:JAMA Netw Open
Main Authors: Dhodapkar, Meera, Zhang, Audrey D., Puthumana, Jeremy, Downing, Nicholas S., Shah, Nilay D., Ross, Joseph S.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2021
Assuntos:
Original Investigation
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8193429/
https://ncbi.nlm.nih.gov/pubmed/34110392
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2021.13224
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