FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

by rss feed | Feb 6, 2025 | Chara Biologics, Dr. Joy Kong, Evolutionary Biologics, FDA Warning Letter, News Feeds, perinatal stem cells

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13...

NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation

by rss feed | Feb 4, 2025 | FDA Warning Letter, INCELL, Interviews, Mary Pat Moyer, MaviX, News Feeds, XoBiologix

A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science...

FDA warns Frontier Biologics as part of its more active trend

by rss feed | Dec 3, 2024 | Chad W. Justice, FDA Warning Letter, Frontier Biologics, News Feeds, perinatal stem cells, Scotty Ray Handley

The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the...

FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

by rss feed | Oct 29, 2024 | CBER, FDA Warning Letter, News Feeds, PalinGen

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on biologics CBER is the part of the FDA that regulates...

Big spike in FDA warning letters to unproven biologics firms

by rss feed | Oct 1, 2024 | Berkeley Biologics, CARsgen, FDA Warning Letter, FDA warning letters, News Feeds

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s...

Regener-Eyes maker gets FDA warning on eye drops

by rss feed | Sep 12, 2024 | Carl R. Harrell, FDA Warning Letter, News Feeds, Regenerative Processing Plant, Regner-Eyes, Vision

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its...