by rss feed | Jan 21, 2024 | Bryan Johnson, FDA Warning Letter, Kimera Labs, MiMedx, News Feeds, weekly reads
Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an...
by rss feed | Oct 5, 2023 | FDA Warning Letter, Neil Riordan, News Feeds, Office of Biological Products Operations, Panama stem cell
Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical...
by rss feed | Aug 31, 2023 | FDA Warning Letter, News Feeds, perinatal stem cells
Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this...
by rss feed | Jan 4, 2023 | FDA Warning Letter, Invitrx, News Feeds, stem cell clinics
The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter....
by rss feed | Jun 21, 2022 | Educational, FDA, FDA untitled letter, FDA Warning Letter, News Feeds
Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes...
