FDA: Regulatory Decisionmaking Workshop Rescheduled

The FDA is rescheduling the second day of a public workshop on drug regulatory decisionmaking for May 12 and extending the comment period for the public docket until June 11.

The workshop, Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decisionmaking, was originally planned for Feb. 12 and 13, but the second day had to be canceled due to snow.

Participants will discuss potential approaches to addressing and relaying uncertainty about a drug’s risks and benefits and identify criteria for developing, evaluating and incorporating those approaches during premarket reviews and postmarket.

The workshop will take place at the agency’s White Oak, Md., campus. Registration is open until May 5.

View the Federal Register notice at www.fdanews.com/ext/resources/files/04/04-16-14-MayWorkshop.pdf. — Lena Freund

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