FDA WARNING_LETTER - Predictive Biotech - August 17, 2020

On August 17, 2020, the FDA issued a Warning Letter to Predictive Biotech, Inc. for marketing CoreCyte™, an umbilical cord-derived product, as a treatment, preventative, diagnostic, or cure for COVID-19. The FDA reviewed the company's websites (www.predictivebiotech.com, https://predtechgroup.com) and social media (www.facebook.com/PredictiveBiotech/) in August 2020.

CoreCyte™ is classified as a human cell, tissue, or cellular or tissue-based product (HCT/P) but fails to meet the criteria for regulation solely under section 361 of the PHS Act (42 U.S.C. § 264) and 21 C.F.R. Part 1271. Specifically, it does not qualify for homologous use (21 C.F.R. § 1271.10(a)(2) and 21 C.F.R. § 1271.3(c)) and appears to exceed minimal manipulation (21 C.F.R. § 1271.10(a)(1) and 21 C.F.R. § 1271.3(f)(1)).

Consequently, CoreCyte™ is deemed an unapproved new drug