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BIO Comments on FDA Framework for Real-World Evidence Program

February 5, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Framework for a Real-World Evidence Program.

As required by the 21st Century Cures Act, FDA created this framework for evaluating the potential use of Real-World Evidence (RWE) to support the approval of a new indication for a drug already approved or to support or satisfy drug postapproval study requirements. According to FDA, the framework is also intended for application to licensed biological products under the Public Health Service Act.

BIO says this important and anticipated framework provides sponsors and stakeholders with necessary information about FDA’s vision for advancing the use of RWE. BIO asks for more information on how FDA intends to engage with and educate stakeholders through workshops or other means. BIO also makes recommendations on how RWE can help satisfy or meet the “substantial evidence” requirement in the regulatory context, how FDA plans to expand its work in developing Real-World Data (RWD) standards, and FDA’s timelines, among other issues.

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FINAL BIO Comment Letter FDA RWE Framework 2-5-19
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