Comment by balls187

FDA doesn’t regulate supplements as medication but food; however Federal consumer protection laws prevent making false claims.

I imagine allowing terminal non-trial participants access is more than just regulatory red-tape.

If understood one of the authors points it was that allowing non-candidates access could speed up approval. I think that is true, but that would require the same regimented process for administering the trial to ensure quality of data. The same would hold if there was an adverse event as well—patients need to be monitored closely to capture data to provide valuable to the clinical research results.