Tag: Regulations

Regulatory Bottleneck 1
Researchers are developing biomedical repair therapies to address multiple age-related diseases at once, yet they are forced to put them through regulatory pathways built for single-disease drugs. The result is delay, duplication, and unnecessary cost precisely when speed matters the most. The single-disease-indication trap Current regulation still treats age-related diseases as if they were a...
Framework
A new publication by an international team of scientists has proposed a new healthcare framework to help older people stay healthier for longer by improving the development of therapies that target age-related diseases. Society is aging, and we need to change healthcare for the better This new publication urges World Health Organization (WHO), governments, and...
Back in November 2017, the FDA announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. Both draft guidance documents had 90-day comment periods, and we at LEAF joined forces with the Niskanen Center to submit comments to the FDA to ensure that the voice of the...