FDA+ guidance roundup: Benefit-risk assessments, RWE to support regulatory decision-making, and more
The FDA on Wednesday unloaded six new draft and final guidance documents across a range of topics, including two new drafts, both thanks to the 21st Century Cures Act, an over-arching one on FDA’s benefit-risk assessments, and one on the data that can be extracted from medical claims and electronic health records and used in regulatory decisions.
For the 20-page draft guidance on benefit-risk assessments, the agency spells out in detail how it goes about conducting its benefit-risk assessments, which it notes become “more challenging” when there are serious safety risks that are life-threatening or associated with significant morbidity.
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