FDA Drug Approval for Biologic Eye Drops, Part 2 - Somewhat Less than the Whole Truth

FDA Drug Approval for Biologic Eye Drops, Part 2 - Somewhat Less than the Whole Truth

(Or, how Biologic Eye Drop manufacturers confuse everyone using the Code of Federal Regulations)

NECESSARY VIEWING: FDA Drug Approval for Biologic Eye Drops Part 1

0:00 Introduction & disclaimers

1:13 Manufacturers playing games with the Code of Federal Regulations. Smoke and mirrors.

1:35 HCT/P - what are they?

2:00 Exempt HCT/P… those lucky, lucky products that don’t require IND, super-expensive clinical trials, NDA and FDA approval!

2:50 How to quality as Exempt - the rules, and how placenta eye drops measure up

5:00 Placenta eye drops: Not Exempt

5:37 Counter-example: Pro-Kera (an exempt HCT/P) compared to biological eye drop (not an exempt HCT/P)

7:10 Dear Regenerative Medicine

7:44 Smoke and mirrors: Regener-Eyes

10:18 What about amniotic fluid? M2 Biologics, StimulEyes, and more smoke and mirrors. Snail and DrB are so impressed.

13:19 Um, amniotic fluid is not a human tissue.

14:00 It’s what they don’t say that matters

14:35 Biologic eye drops have real adult supervision (the Food and Drug Administration). Is DrB a broken record?

15:32 What manufacturers must do before legally selling a biologic product (“In order to lawfully market a biological product, a biologics license must be in effect”)

16:15 Summary: Regenerative Medicine Eye Drops - Magic Proteins! What Regenereyes and Stimuleyes pretend to be, and what the problems with that are

17:00 What kind of laws are being broken by those who purchase and/or sell biologic eye drops? (“Adulterated and Misbranded”)

17:53 Regenerative Medicine: Misleading patients (and providers) for profit) Snail wonders: “If they can’t proof their ad copy, can they clean their lab?”