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Regulatory front

Aug. 10, 2017
As part of its commitment under the PDUFA V agreement, the FDA will hold a public meeting Sept. 18 for a discussion on the structured assessment of benefits and risks in the drug regulatory process. The meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, ways to incorporate patient perspectives into the assessments and methods to advance the assessments. The sessions will look at the entire drug development life cycle, including premarket drug review and postmarket safety surveillance, according to a notice published in Wednesday's Federal Register. Registration is due by Sept. 11.
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