RWE: FDA drafts guidance on RWE submissions

09-05-2019

RWE: FDA drafts guidance on RWE submissions

(Source: RAPS 2019-05-10)

With an eye toward better tracking the use of real-world data (RWD) to generate real-world evidence (RWE), the US Food and Drug Administration (FDA) on Wednesday drafted guidance to help sponsors provide information to the agency on their use of RWD and RWE in a uniform format.

The uniform format is meant to help the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) track certain types of submissions using RWE under an investigational new drug application (IND), new drug application (NDA) or biologics license application (BLA).

Relevant submissions may include RWE used to support study objectives, such as: “IND submissions for randomized clinical trials that use RWD to capture clinical outcomes or safety data, including pragmatic and large simple trials; New protocols for single arm trials that use RWE as an external control; Observational studies that generate RWE intended to help to support an efficacy supplement; Clinical trials or observational studies using RWE to fulfill a postmarketing requirement to further evaluate safety or effectiveness and support a regulatory decision.”

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