Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020.
A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.
The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, […]
The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, […]