← FDA GUIDANCE
FDA GUIDANCE · DRAFTSeptember 18, 2024
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry
What this record is not
Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.
Status
Draft
Topic
Real World Data / Real World Evidence (RWD/RWE)
Issue date
September 18, 2024
This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.
READ THE FULL GUIDANCE
The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.
View on fda.gov →