With an aim to better explain how a drug’s benefits and risks inform regulatory decision-making, FDA said Friday it expects to draft guidance on the topic by the end of June 2020.
As outlined in the latest Prescription Drug User Fee Act (PDUFA VI) commitment letter, this draft guidance will: Illustrate the application of the benefit-risk framework throughout a drug’s lifecycle, “using a case study approach, if appropriate,” discuss interactions between a sponsor and FDA during development to understand the severity of disease and the extent of unmet medical need, and discuss appropriate approaches to communicate publicly the agency’s thinking on a benefit-risk assessment.
Background
The Benefit-Risk Framework (BRF) has two key elements for new drug applications (NDAs) and…
