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Happenings from Across FDA

If your email program has trouble displaying this email, view as a webpage. CDER Patient-Focused Drug Development Happenings from Across FDA FDA Issues Draft Guidance on Benefit-Risk Assessments for New Drug and Biological Products On September 29, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance for industry, "Benefit-Risk Assessments for New Drug and Biological Products." This guidance intends to clarify how considerations about a drug's benefits, risks, and risk management options factor into FDA's premarket and postmarket regulatory decisions about new drug applications or biologics license applications.  These important considerations include: The therapeutic context in which the drug will be used; The evidence submitted in the premarket application and/or generated in the postmarket setting that informs FDA's understanding of the benefits and risks of the drug; Remaining uncertainties about the drug's benefits and risks; FDA's regulatory options to reduce uncertainties and manage risks. The guidance also discusses several topics of relevance to FDA's benefit-risk assessment, such as how patient experience data can be used to inform the benefit-risk assessment and how sponsors can inform FDA's benefit-risk assessment through the design and conduct of the development program and through the presentation of benefit and risk information in a drug product marketing application, as well as the potential for additional benefit-risk analyses to help inform the overall benefit-risk assessment in some circumstances. FDA is accepting comments and suggestions on this draft guidance. To submit a comment to FDA, please refer to docket No. FDA-2020-D-2316. For more information about this guidance, please see the guidance snapshot. Upcoming Public Workshop on A Practical Research Agenda for Treatment Development for Stimulant Use Disorder On October 18, 2021, the Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), is hosting a virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder. Building on the October 6, 2020 PFDD Meeting for Stimulant Use Disorder, this public workshop provides an opportunity for meeting participants (including academic researchers, medical product developers, community representatives, and other interested parties) to respond to a proposed practical research agenda that focuses on innovation in clinical trial design and candidate endpoints for the evaluation of potential treatments for stimulant use disorder. To register for the workshop, and for more information, please click here. To contact FDA's CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.  If this message was forwarded to you and you would like to subscribe to this free email subscription service, please visit our CDER PFDD Homepage and click the button "Subscribe to Email Updates" at the top of the page.

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