Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

On 29 November 2021 the FDA published the draft guidance for industry. Comments may be submitted by 28 February 2022.

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, was intended to accelerate medical product development and bring innovations and advances 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). In response to the requirements in section 505F, the Food and Drug Administration (FDA) created a framework for a Real-World Evidence (RWE) Program to evaluate the potential use of real-world evidence to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support or satisfy post approval study requirements.

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