The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into the agency’s decisions on whether to approve a new drug application (NDA) or biologics license application (BLA).
The document also addresses how patient experience data may be used to inform benefit-risk assessments and the best time for sponsors to interact with FDA to discuss benefit-risk information in their applications.
The guidance was developed in accordance with goals set in the Prescription Drug User Fee Act of 2017 (PDUFA VI) under the FDA Reauthorization Act of 2017 and the 21st Century Cures Act and finalizes a draft guidance issued in September 2021 (RELATED: FDA draft guidance outlines criteria for conducting benefit/risk assessments, Regulatory Focus 1 October 2021)…
