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

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Outing Regenereyes, Part 1 - Introduction

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Outing Regener-Eyes - Trailer