The gatekeeper for whether new drugs, devices, and treatments reach patients.
FDA decides which drugs, devices, and treatments are safe and effective enough to reach patients. Unlike other agencies, it mostly relies on evidence generated by others.
FDA has no clear public standard for when real-world data is strong enough to rely on, its approval and post-market safety systems run on separate tracks, and clinical trials often don't reflect the patients who will actually use a product.
Publish clear public rules for when real-world evidence can support specific types of FDA decisions.
Connect approval decisions to post-market monitoring, so the uncertainties accepted at approval get tracked and resolved.
Make sure clinical trials enroll the people who will actually use the product, and say so when they don't.