Integrated assessments: FDA consults on its integrated review documentation
The US Food and Drug Administration wants stakeholder feedback on its integrated assessment and integrated review documentation for new drugs as part of its New Drugs Regulatory Program Modernization effort.In contrast to the agency’s previous review documentation, which was featured separate review documents from each of the review disciplines, and its multidisciplinary “Unireview” process, which featured a single review document with sections provided by each review discipline, FDA said the integrated review documentation “is the product of an interdisciplinary team assessment process that provides collaborative discussions of key review issues that span multiple disciplines and includes resolution of important issues pertinent to benefit-risk assessments.” The Integrated Review documentation templates include three main parts: an executive summary, interdisciplinary assessment, and additional analyses and information.
So far, FDA has implemented the integrated review documentation for new molecular entities (NMEs), original biologics license applications (BLAs) and certain efficacy supplements, though the agency said it plans to expand the documentation to other applications soon.
“This interdisciplinary approach facilitates clarity of decision making and ensures input from relevant disciplines in the consideration of scientific issues,” the agency said.
FDA is now seeking input on the integrated assessment and integrated review documentation in an effort to ensure that the documentation meets stakeholders’ needs. Alongside the request for comments, FDA published integrated review documents for three products, Nexviazyme (avalglucosidase alfa-ngpt), Rukobia (fostemsavir), and Rezdiffra (resmetirom), as examples of the new template.
FDA said it wants input on five questions raised in the public consultation to ensure that the integrated review documentation is useful and meets stakeholders needs.
Specifically, FDA wants to know whether there are any information stakeholders are having trouble finding in the new documentation, and whether stakeholders are able to use the integrated review documentation for the same purposes as before.
The agency also asked for recommendations on how to improve the integrated assessment and integrated review documentation, and for stakeholders’ views on the “advantages and disadvantages of an interdisciplinary assessment presentation of key review issues and the resultant integration of the assessments of multiple disciplines into a single integrated review document.”
Additionally, FDA asked whether stakeholders feel the integrated review document offers clarify on benefit-risk assessments and whether the issues raised by the review team were “clear and understandable.”
Stakeholders can comment on the guidance on www.regualtions.gov under docket no. FDA-2024-N-3878 through 12 December.
Federal register notice
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