70 research outputs found
Aggregate Analysis of the Export Petition and Waiver Process: A Pharmaceutical Industry Perspective
Strategies for a Label Claim or Indication in the Context of Robust Point Estimates From Historical Data
Pre—Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products
Patient Experience Data in US Food and Drug Administration (FDA) Regulatory Decision Making: A Policy Process Perspective
Is It Possible to Claim Efficacy if One of Two Trials is Significant While the other Just Shows a Trend?
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