Access versus evidence: The regulators' dilemma
- PMID: 29871504
- DOI: 10.1177/1740774518770660
Access versus evidence: The regulators' dilemma
Comment in
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The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation.Clin Trials. 2018 Jun;15(3):243-246. doi: 10.1177/1740774518770657. Clin Trials. 2018. PMID: 29871507 No abstract available.
Comment on
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The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.Clin Trials. 2018 Jun;15(3):219-229. doi: 10.1177/1740774518770648. Clin Trials. 2018. PMID: 29871509
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