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FDA Target Rogue Gene Therapy Clinics

16-Nov-2017

Key points from article :

FDA issued new guidelines for expedited review of stem cell and gene therapies.

Will crack down on clinics offering unproven versions of those treatments.

Only two products that qualify as gene therapy have been approved.

Patients have been blinded after fat-derived cells were injected into their eyes.

Previoulsy practitioners argued that they do not come under the agency’s jurisdiction.

Mentioned in this article:

Click on resource name for more details.

Food and Drug Administration (FDA)

Ensuring safety of drugs, medical supplies and food which is used daily.

Kite Pharma

Company that develops cancer immunotherapy products.

Novartis

Global medicines company for developing and producing drugs.

Peter Marks

Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration

Scott Gottlieb

American physician and investor.

Topics mentioned on this page:
Gene Therapy