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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2021-D-0548
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The 21st Century Cures Act, signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this action, calling for FDA to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).