Home Access Health submits PMA for home-use HIV test system.
This article was originally published in The Gray Sheet
Executive Summary
HOME ACCESS HEALTH SUBMITS PMA FOR HOME-USE HIV TEST SYSTEM and asks FDA to expedite review of the premarket approval application, the Chicago-based start-up announced June 1. Home Access Health Corp., formerly known as Anonymous Test Services, says it submitted the PMA following the mid-March completion of multi-center Phase III clinical trials involving more than 1,200 subjects.
You may also be interested in...
EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: