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USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products

A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food and Drug Administration Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.


The FDA's drug regulatory context is defined as a benefit-risk assessment, which involves making a judgment as to whether a drug's benefits (with their uncertainties) outweigh its risks (with their uncertainties and approaches to managing risks) under the conditions described in its approved label. The benefit-risk assessment becomes more challenging in cases where the potential for serious risks is identified or expected to exist, e.g., risks that are life-threatening or associated with significant morbidity.

Using this guidance, drug sponsors and other stakeholders can gain a better understanding of the premarket and postmarket regulatory decisions the FDA makes regarding new drug applications and biologic license applications (NDAs) based on considerations of the drug's benefits, risks, and risk management options.


In this guidance, the CDER and the CBER outline important considerations that should be taken into account when making benefit-risk assessments. This includes decisions regarding any regulatory requirements for approval, such as inclusion of a boxed warning in approved labeling, postmarketing study requirements and commitments, and risk evaluation and mitigation strategies (REMS).


Using patient experience data to inform benefit-risk assessments is discussed, along with how sponsors can contribute to FDA's benefit-risk assessment by designing and conducting development programs.


To know more about the FDA’s Benefit-Risk Framework and Appropriate Interactions Between a Sponsor and FDA During Drug Development to Inform Benefit-Risk Planning click this LINK.


Also on 24th October, 2023 the FDA released a draft guidance "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers" that will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products.





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