Sec. 905. RISK-BENEFIT FRAMEWORK

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## SEC. 905 RISK-BENEFIT FRAMEWORK Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: “The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug.”.

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U.S. Code

New drugs
§ 355

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Sec. 905

RISK-BENEFIT FRAMEWORK

U.S.C.§ 355

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