publication date: May. 10, 2019

Real World Evidence

FDA issues draft guidance on using real world data in drugs, biologics

By Matthew Bin Han Ong

FDA has issued a draft guidance that describes the types of real world data and real world evidence that the agency would accept as part of regulatory submissions for drugs and biologics.

The draft guidance, published May 8, is intended to get input on FDA’s proposal to “encourage sponsors and applicants who are using RWD to generate RWE as part of a regulatory submission to identify in the cover letter that the submission contains RWE in a simple, uniform format,” agency officials said in a statement.

The comment period is open through the first week of July.

When implemented, FDA anticipates that this approach will allow the agency to identify and track RWE submissions, monitor outcomes and ensure appropriate review expertise.

“This is a harbinger of many more things to come at FDA,” Amy Abernethy, FDA deputy principal commissioner, said to The Cancer Letter. Abernethy, who joined the agency in February, is also acting chief information officer (The Cancer Letter, Dec. 17, 2018).

According to the draft guidance, submissions for drugs and biologics may include RWE used to support study objectives. For instance:

Investigational New Drug 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Clinical trials or observational studies using RWE to fulfill a postmarketing … Continue reading FDA issues draft guidance on using real world data in drugs, biologics

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