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.
Regener-Eyes to DEF: “None of your business”
A “Cease and Desist Demand” letter from Regener-Eyes LLC to Dry Eye Foundation: “It’s none of your business.”
StimulEyes
StimulEyes 1.0; StimulEyes 2.0; the FDA Warning Letter to the manufacturer of StimulEyes 1.0; and… what comes next?
You Won’t Eat GMO But You’ll Put This In Your Eyes - Part 3A
StimulEyes - The Next Pretender OTC?
“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.
Which Regener-Eyes will be on display at American Academy of Optometry?
Will the real Regener-Eyes please stand up?
Compare Regener-Eyes’ original vs revised descriptions submitted to the American Academy of Optometry - and compare those to DailyMed and Regener-Eyes’ marketing handouts.
Sept 29, 2022 Open Letter to RPP
An Open Letter from Dry Eye Foundation to Regenerative Processing Plant LLC: “What is in Regener-Eyes?”
Diagnosing Scam Pharma, Part 4A - Playing Whac-A-Mole with Regener-Eyes LLC
Staying one step ahead of the feds. Bye-bye, “biologic”! Look, an indication! New OTC DailyMed listings. Are they lying to patients? Are they lying to the FDA? Oh, and where exactly does glycerin come from? No mole holes left.
Which one is it, Regener-Eyes?
Regener-Eyes is spreading contradictory information at trade shows.
The Placebo Effect, Part 2 - Why Clinical Trials Need Placebo Control
Dr B describes this one as “fairly geeky and not open to much snark”.
The Placebo Effect, Part 1 - What Is the Placebo Effect?
Belief is powerful. It’s also contagious. You can catch it from your doctor.
Diagnosing Scam Pharma, Part 3 - It Has a Mermaid on It - It Must Be Okay!
DrB talks about Regener-Eyes past history (predecessor products) and the recent changes to their website. Gosh, it's nice to be noticed!
Vitti Labs Warning Letter
FDA warning letter to Vitti Labs and why this is relevant to other biologic eye drop manufacturers.
You Won’t Eat GMO But You’ll Put This In Your Eyes, Part 2
The GoodFellas of StimulEyes: M2 Biologics, Neobiosis, Truax Patient Services