FDA to M2Biologics: Not lawful to market StimulEyes
FDA’s biologics internet surveillance team sent a letter on 11/17/22 to M2Biologics, the makers of StimulEyes (amniotic fluid eye drops) about their failure to obtain a biologics license.
FDA to Regener-Eyes: “Can’t lawfully market it until proven safe, pure and potent.”
A letter from the internet surveillance division of the Center for Biologics Evaluation and Research at the FDA.
“Prescribing” Biologic Eye Drops
Just because a doctor prescribed it does not make it a prescription drug (which implies credibility, like it’s been vetted by someone). There are many paths to prescribing, but only one path to a prescription drug.
