FDA Combo HIV Therapy Review Process May Delay Availability, Rep. Waxman Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency's new regulatory framework for expedited review of fixed-dose combination antiretroviral drugs is "highly misleading," Rep. Waxman says in letter to HHS Secretary Thompson. Waxman believes the proposal will delay purchase of generic combo therapies used outside the U.S.