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FDA Issues Drug Development Benefit-Risk Assessment Guidance Document

The agency has released its “Benefits-Risk Assessment for Human Drug and Biological Products” final guidance to provide a clearer understanding of the FDA's decision-making context and benefit-risk considerations in drug development.

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The FDA has announced the availability of a final guidance for industry entitled “Benefit-Risk Assessment for Human Drug and Biological Products.” The intent of the guidance is to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug’s benefits, risks, and risk management options factor into the FDA's pre- and post-market regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs).

The document also provides patients and other stakeholders with further insight into the key issues that inform the FDA’s assessment of benefit and risk, and a clearer understanding of how these issues fit into the regulatory framework of drug development and evaluation.

The guidance discusses how sponsors, through their decisions and activities throughout the drug lifecycle, can inform FDA’s benefit-risk assessment, as well as opportunities for interaction between the FDA and sponsors to discuss benefit-risk considerations. It articulates important considerations that factor into the Center for Drug Evaluation and Research’s (CDER) and the Center for Biologics Evaluation and Research’s (CBER) benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment.

It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as unique considerations for benefit-risk assessments that inform regulatory decision-making that occurs in the post-market setting.

The guidance document was developed in accordance with goals associated with the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act. It finalizes the draft guidance of the same title issued in September 2021.

To download a copy of the “Benefit-Risk Assessment for New Drug and Biological Products” guidance document, click here.


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