Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.
作者信息
Shahzad Mahnum, Naci Huseyin, Wagner Anita K
机构信息
Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
出版信息
JAMA. 2023 Mar 7;329(9):760-761. doi: 10.1001/jama.2023.0625.
Abstract
摘要
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