Categories
Presentation

VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies

A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.

Categories
Alert

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 government likely to be lawful, and definitely beneficial to the government and the public. The court creates a new standard for dismissal, joining the standards articulated in Sequoia Orange […]

Categories
Alert

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 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, […]

Categories
Alert

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 (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, […]

Categories
Alert

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’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got […]