FDA

Weekly recommended reads including asymmetric division & chromatin

Asymmetric division and chromatin

One of my favorite types of papers are those on stem cells and chromatin, and a new one in Current Biology caught my eye this week. My own lab website has the URL chromatin.com so that says something. You can also read more about our research here. Recommended reads: chromatin and stem cells, more Asymmetric …

Weekly recommended reads including asymmetric division & chromatin Read More »

Translating the FDA’s Q&A on end of stem cell grace period

The Rosetta Stone, The FDA

The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers …

Translating the FDA’s Q&A on end of stem cell grace period Read More »

FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics …

FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders Read More »

Recommended reads: jobs, FDA letter, & The Niche new look

the body building fda letter the niche

During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I …

Recommended reads: jobs, FDA letter, & The Niche new look Read More »

FTC fires off many warnings to stem cell clinics on COVID-19

BioXcellerator-warned-by-FTC-over-stem-cells-for-COVID-19-has-many-promotional-videos.-This-is-a-screenshot-from-one.

The FTC has sharply increased its oversight activities against stem cell and regenerative clinic firms. These new actions include quite a few warning letters. Here is the FTC database for COVID-19-related warning letters. Note that recently the FTC added a new, helpful option to view all of its warning letters here. It’s a good source …

FTC fires off many warnings to stem cell clinics on COVID-19 Read More »

Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts

Anand-Srivastava

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of …

Politics & FDA clearance of 2 stem cell clinic COVID-19 efforts Read More »

Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy

Levy-et-al-MSCs-Science-Advances

Ready for the latest recommended weekly reads in the world of stem cells and the regenerative medicine space including a bunch of important new FDA posts & changes? This post has quite a lot on the FDA since it had a very big week with several new items of major importance to the cellular and regenerative …

Weekly reads: FDA news, goosebump stem cells, MSCs, autophagy Read More »

Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT

EUCYT-CEO-Travis-Bird

The FDA dropped a lengthy, extremely critical warning letter on a supplier of unproven exosome product called EUCYT Laboratories. For broader context, exosome therapy has somehow burst onto the scene when there’s no good data yet in my view to back up its use in the clinic. The FDA is taking notice with letters already sent …

Getting 30 F grades? FDA Strongly Warns Exosome Firm EUCYT Read More »