Clinical Investigator’s Warning Won’t Trip Up First HIV Home Test Launch

An investigator has been warned for failing to comply with state laws, the study protocol and IRB requirements during a clinical trial of the first FDA-approved home HIV test, OraQuick. But the letter is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer said, because the company proactively removed the site’s data from key analyses and product labeling.
Clinical Trials Advisor