BioCentury
ARTICLE | Regulation

FDA guidance clarifies use of real-world data for label expansions

Agency articulates thinking on use of evidence complementary to data from randomized trials

October 16, 2021 12:48 AM UTC

The biopharma industry has until Nov. 29 to comment on draft guidance from FDA that clarifies for manufacturers the circumstances under which the agency will consider adding follow-on indications for approved drugs based largely on real-world data.

Although FDA has already approved supplementary applications based on real-world evidence, the document articulates the agency’s thinking for drug developers that are seeking label expansions based on submissions of data collected from sources complementary to clinical evidence, such as electronic health records, registries, medical claims and patient-generated information...