Archive
Wade Emmert
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’…