FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals
FDA Commissioner Marty Makary announced the elimination of barriers requiring individual patient consent for real-world data submissions in drug and device applications, allowing broader de-identified data from sources like cancer registries and insurance claims to streamline approvals1.
This change aligns with President Trump's push to cut red tape, reduce costs, and speed up cures; only 12 drugs used real-world data in approvals over the last 14 years due to prior onerous requirements1.
FDA is shifting from requiring two default clinical trials to one well-controlled, statistically powerful trial for most drugs, except rare diseases, as part of early-phase reforms1.
The agency launched FDA-RWE-ACCELERATE initiative and Sentinel 3.0 for better RWE integration and safety signal detection, complementing broader health strategies3.
Additional efforts include a September 2025 request for comments on real-world evaluation of AI-enabled devices and ongoing RWE guidance updates4.
Sources:
1. https://www.foxbusiness.com/media/fda-rolls-back-red-tape-move-aligned-trump-push-speed-up-new-cures
3. https://www.fda.gov/news-events/speeches-fda-officials/regulatory-submissions-real-world-evidence-successes-challenges-and-lessons-learned-09232025
4. https://www.covingtondigitalhealth.com/2025/10/fda-requests-public-comment-on-real-world-evaluation-of-ai-enabled-medical-devices/