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BIO Comments on FDA Draft Guidance, Benefit-Risk Assessment for New Drug and Biological Products

November 29, 2021

On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the FDA makes about new drug applications (NDAs) submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as biologics license applications (BLAs) submitted under section 351(a) of the Public Health Service Act (PHS Act). In the comment letter, BIO offered suggestions regarding additional emphasis on Patient Experience Data (PED), communicating benefit-risk, sponsor-FDA interactions and discussions, consistent and transparent implementation, methodologies, therapeutic context, and other considerations. While the full comment letter contains much more detail on both the overarching and line edit suggestions; overall, BIO commended the Agency on recognizing the importance of enabling meaningful patient input to inform regulatory decision-making in the context of FDA’s benefit-risk assessment, while stressing the importance of consistency and transparency. BIO also requested further clarification on a variety of topics mentioned within the guidance, such as how FDA determines that limiting the indication statement is justified based on the Agency’s benefit-risk assessment and how the FDA will communicate to the public the Agency’s thinking on a product’s benefit-risk assessment, such as through product-specific discussions using the benefit-risk framework at AC meetings.

Download Full Comments Below
BIO Comment Letter Benefit Risk Assessment Guidance
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