FDA Drug Approval for Biologic Eye Drops, Part 1 - No Shortcuts Allowed
FDA Approval for Biologic Eye Drops, Part 1 - No Shortcuts Allowed
0:00 Intro and disclaimers
1:09 The FDA new drug approval process: overview, pre-clinical, clinical trials, NDA, and post-market
5:05 Regenerative medicine eye drops: manufacturers, biologic sources, protein functions, and ads
7:29 How these products are regulated: Therapeutics Biologics Applications (BLA)
8:34 Regener-Eyes, StimulEyes and Lacri-Complex are not FDA approved - and they should be
10:33 Don’t be distracted by HCT/P
12:06 Conclusions