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BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation

December 23, 2020

On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” In its comments, BIO stated that the FDA’s new integrated review documentation is much improved from the older template as it is easier to navigate and provides greater clarity and transparency on key information considered in the review process. However, BIO requests that the Agency ensures any relevant information is not removed or omitted as the new documentation is implemented, and that this information remain publicly available. BIO also proposed additional strategies for the Agency to utilize in increasing transparency in the regulatory approval process. Lastly, given current technology, BIO encouraged the FDA to consider providing the information included in the integrated review in an electronic format that can easily be searched across products.  

Download Full Comments Below
BIO Comment Letter on New Drug Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
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