Zdrowie i gospodarka · 10/01/2014

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making: Public Workshop Request for Comments

The FDA is hosting a public workshop to discuss approaches for addressing and communicating uncertainty in drug regulatory decision-making, as part of its commitment under the Prescription Drug User Fee Act (PDUFA V). The workshop will explore potential methods for evaluating benefits and risks in human drug reviews.