21st Century CURES Act by FDA: section 3022 outlines framework for FDA to consider NOT only randomized controlled trials (RCTs) but real world evidence e.g. observational studies! why don't THEY??
by Paul Alexander
Why did the FDA demand only RCTs) and this precluded good HCQ and IVM & other key tools for COVID responding, when they had a duty and actual ACTs saying use RWE & observational studies?
RWE: REAL WORLD EVIDENCE
SOURCE:
https://www.hhs.gov/sites/default/files/Gruber_16x9_Comments%20from%20FDA_Remediated.pdf
SOURCE:
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
See Lee Mueller’s substack, great scholarship on this, hence I add: