Archive
October 2020
VIDEO: TBCE Stem Cell Stakeholder meeting
https://youtu.be/8De4ocoV8tY Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020.
HHS Renews Public Health Emergency Declaration through January 20, 2021
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed…
VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies
https://youtu.be/70S8A7meICI A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.
Professional Relators Have No Right to Sue for Beneficial Conduct
The Seventh Circuit determined that professional qui tam relators formed as “investment vehicles for financial speculators” should not be allowed to challenge conduct determined by the…
FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
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…
FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests
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…
Unapproved and Misbranded COVID Treatments Get FDA Attention
There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’…