FDA Lays Out Framework on Use of Real-World Evidence

The FDA released a new framework outlining how the agency will use real-world evidence to assess the effectiveness of drugs.

The agency says it will consider real-world evidence to support changes to approved product labeling relating to amending the dosage, population or route of administration. In addition, it will consider, on a case-by-case basis, whether a trial design used to generate RWE can provide sufficient evidence to answer regulatory questions, and whether the study was conducted according to FDA requirements.

Commissioner Scott Gottlieb noted the agency has already used real-world evidence and real-world data in certain postmarket scenarios. For example, the agency’s Sentinel system has produced real-world data that eliminated the need for postmarketing studies on nine potential safety issues in five products, he said.