FDA Issues Draft Guidance on Factors Considered in Benefit-Risk Assessments for Drug and Biological Products Today, the U.S. Food and Drug Administration issued the draft guidance for industry, "Benefit-Risk Assessment for New Drug and Biological Products." This guidance intends to clarify how considerations about a drug's benefits, risks, and risk management options factor into FDA's premarket and postmarket regulatory decisions about new drug applications or biologics license applications. These important considerations include: - The therapeutic context in which the drug will be used;
- The evidence submitted in the premarket application and/or generated in the postmarket setting that informs FDA's understanding of the benefits and risks of the drug;
- Remaining uncertainties about the drug's benefits and risks;
- FDA's regulatory options to reduce uncertainties and manage risks.
The guidance also discusses several topics of relevance to FDA's benefit-risk assessment, such as how patient experience data can be used to inform the benefit-risk assessment and how sponsors can inform FDA's benefit-risk assessment through the design and conduct of the development program and through the presentation of benefit and risk information in a drug product marketing application, as well as the potential for additional benefit-risk analyses to help inform the overall benefit-risk assessment in some circumstances. FDA is accepting comments and suggestions on this draft guidance. To submit a comment to FDA, please refer to docket No. FDA-2020-D-2316. For more information about this guidance, see the guidance snapshot.  | 
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