International Programs
Presidential Emergency Plan for AIDS Relief (PEPFAR)
The Liaison for all FDA activities under the President’s Emergency Plan for Aids Relief (PEPFAR) also resides within the FDA Office of International Program’s Asia and Africa Office. The PEPFAR Liaison serves as the FDA point of contact with all outside entities in coordinating Agency activities dealing with PEPFAR, including those associated with drug firms seeking to participate in the expedited review process for antiretroviral (ARV) therapies for use in the PEPFAR focus countries. The Liaison is also the point of contact with the World Health Organization’s (WHO) Prequalification Unit to facilitate the sharing of confidential information to leverage review of antiretroviral products and facilitate posting of FDA tentatively approved and approved ARVs listed on the WHO website. Programs that have developed as a result of the PEPFAR initiative such as the White House Private Public Partnership for Pediatric Therapies, is also coordinated under this umbrella.
- AIDS Drugs under President’s Emergency Plan for AIDS Relief (Table)
(Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan)
FDA Marks More than 150 HIV/AIDS Drugs Authorized for Purchase Under PEPFAR
- FDA News Release: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief
Video: FDA Approves More Than 150 Antiretroviral Drugs for Global HIV/AIDS Relief Consumer Update: Improving Access to HIV/AIDS Drugs Abroad Message by Dr Margaret Chan of the World Health Organization on the 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR Remarks of Dr. Mirta Roses, Director, Pan American Health Organization PEPFAR Efent Oct. 6, 2008 Remarks by the Ambassador of Tanzania to the United States FDA Gives Tentative Approval to New Generic AIDS Drug in Association with the President's Emergency Plan for AIDS Relief Improving Access to HIV/AIDS Drugs Abroad