Search Results for: warning letter

Upbeat Burt team pub on stem cells for MS comes with uneasy back story

Stem cells for MS, Types-of-Multiple-Sclerosis

Stem cells for MS? How promising is that? A new paper gives stronger reason for hope, but unfortunately this story is more complex than it seems on first glance. New Paper The idea of using a stem cell-related approach to treat multiple sclerosis (MS) has been around for a long time holding major promise, but […]

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When the state & ‘rogue’ scientists collide: case of China & CRISPR baby guy He Jiankui (贺建奎)

He-Jiankui-贺建奎

What happens next to He Jiankui (贺建奎) or as some people now refer to him, the “CRISPR baby guy”? China has a challenging situation to resolve here, but such conflicts between scientists and governments have happened regularly in history. When scientists go “rogue” (i.e. don’t conform to norms or ethical standards in an extreme way or

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FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely

Dr.-Scott-Gottlieb

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a

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Stem cell eye drops? Skepticism of American Academy of Stem Cell Physicians (AASCP)

AAOSCP-meeting

What is the AASCP? I’ve been hearing more recently about something called the American Academy of Stem Cell Physicians (variously AAOSCP or AASCP). Its name has the sound of an organization like some traditional medical academy such as the American Academy of Internal Medicine, but my sense is that this is a totally different kind

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FDA outlines potential crackdown on Clinicaltrials.gov offenders

Anderson-et-al-Clinicaltrials.gov_

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance

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