Home > Newsletters > FDAnews Device Daily Bulletin > Clinical Site’s Problems Won’t Trip Up Launch of First HIV Home Test
FDAnews Device Daily Bulletin
Aug. 16, 2012 | Vol. 9 No. 161
Clinical Site’s Problems Won’t Trip Up Launch of First HIV Home Test
An FDA warning letter issued to a researcher involved in clinical trials of the first home HIV test is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer said. OraSure Technologies’ OraQuick HIV home test was approved by the FDA last month and is expected to hit retail outlets nationwide in October.
Devices & Diagnostics Letter
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.