accelerated approval regulation permits companies to seek approval of drugs
for serious or life-threatening diseases when the drug provides meaningful
therapeutic benefit over existing therapies. Under these procedures, the FDA
may approve drugs based on surrogate endpoints, such as CD4+ cell counts that
reasonably predict that a drug provides clinical benefit. The company is then
required to confirm this clinical benefit through additional human studies
to be completed after marketing approval. The accelerated approval regulation
provides for removal of the drug from the market if further studies do not
confirm the clinical benefit of the therapy.
Alan B. Stone, and Penelope J. Hitchcock. Vaginal Microbicides for Preventing
the Transmission of HIV. AIDS 1994, 8 (suppl 1):S285-S293.
recently, the United Nations' response to HIV/AIDS was carried out primarily
by the World
Health Organization's Global Programme on AIDS. On January 1, 1996 the
U.N. launched UNAIDS,
co-sponsored by six U.N. agencies to strengthen coordination and focus support
for HIV/AIDS activities at the global and country levels. UNAIDS has established
three mutually reinforcing roles: to be a major source of policy development
and research; provide technical support; and be an advocate for comprehensive,
multi-sectoral responses to the pandemic.
S. Paauw, Marjorie D. Wenrich, J. Randall Curtis, Jan D. Carline, Paul G.
Ramsey. Ability of Primary Care Physicians to Recognize Physical Finding
Associated with HIV Infection.JAMA.