Federal Register
Notice: FDA is making available a guidance for industry entitled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV. The guidance is intended to encourage sponsors to submit to FDA applications for fixed dose combination (FDC), co-packaged, and single-entity versions of antiretroviral drugs for treating human immunodeficiency virus. The availability of a wide range of safe and effective antiretroviral products may help facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic. To download the guidance, click here. To view this notice, click here.