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Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

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Though you possibly can touch upon any steerage at any time (see 21 CFR 10.115(g)(5)), to make sure that the FDA considers your touch upon a draft steerage earlier than it begins work on the ultimate model of the steerage, submit both on-line or written feedback on the draft steerage earlier than the shut date.

If unable to submit feedback on-line, please mail written feedback to:

Dockets Administration
Meals and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written feedback ought to be recognized with this doc’s docket quantity: FDA-2021-D-1214


The 21st Century Cures Act (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 Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this section, FDA created a framework for a program (RWE Program) to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making.

FDA is issuing this guidance as part of its RWE Program to satisfy, in part, the mandate under section 505F of the FD&C Act to issue guidance about the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support postapproval study requirements.



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