Search Results for: fda warning

Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

January 21, 2024 / By / 10 Comments
AXIOFILL, MiMedx

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 amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter …

Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial Read More »

Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO

August 13, 2022 / By / Leave a Comment
Timothy D. Hunt, new CEO of ARM, Alliance for Regenerative Medicine

I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …

Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO Read More »

Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR

July 2, 2022 / By / Leave a Comment
Grant writers handbook, grants cartoon

The last six months I’ve been spending even more time than usual writing NIH grants (and a few others). The last two weeks have been especially busy on this front as I am getting an R01 renewal out the door. My paper reading lately has been mostly related to the grant writing I’m doing. Still, …

Weekly reads: NIH grants, side effect of darker hair, FDA warning, CRISPR Read More »

What is an FDA warning letter & how should firms respond

June 22, 2022 / By / 10 Comments
FDA warning letter

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 what such a letter means and what steps come …

What is an FDA warning letter & how should firms respond Read More »

Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs

November 28, 2021 / By / 3 Comments
CRISPR-baby

If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …

Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs Read More »

Recommended reads: FDA warning, COVID updates, stem cell pubs

June 8, 2022 / By / 1 Comment
Tao-et-al-Stem-Cell-Reports-2020-Fig.-1c-small

What’s been going on in the stem cell and regenerative medicine field over the past week and what are some worthwhile things to read? Today’s post has recommended recent reads from the scientific literature and the media. I’ve also got our weekly stem cell/regenerative medicine quiz question and the answer to last week’s. You can …

Recommended reads: FDA warning, COVID updates, stem cell pubs Read More »

‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter

February 1, 2021 / By / 7 Comments
Habib-Torfi

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning …

‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter Read More »

Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

June 8, 2022 / By / 3 Comments
Stemgenex

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many …

Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex Read More »