Knowledge
Regulatory
FDA, EMA, MHRA, PMDA — what approval means, how it differs between agencies, and what 'Research Use Only' actually means.
4 questions
What does 'FDA-approved' actually mean?
FDA approval means the compound has been shown safe and effective for a specific indication in adequate and well-controlled trials, and its manufacturing meets defined quality standards.
What does 'Research Use Only' mean?
Research Use Only means the compound is legally sold as a research reagent for laboratory investigation, not as a therapeutic drug. It has not been approved for human use in any indication.
How does EMA approval differ from FDA approval?
EMA and FDA are the drug regulators for the EU and US respectively. They apply similar scientific standards but reach independent decisions — some drugs are approved in one region and not the other.
What are investigational compounds?
Investigational compounds are drugs in active clinical development but not yet approved for any indication. Retatrutide and the intranasal PT-141 in earlier development are examples.