Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Guidance for Industry

Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Guidance for Industry





FDA In Brief: FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in pediatric patients, as part of efforts to end HIV infection



FDA In Brief > FDA In Brief: FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in pediatric patients, as part of efforts to end HIV infection

The U.S. Food and Drug Administration today issued two final guidances for industry to help product sponsors understand the FDA’s thinking about preventive treatments for HIV as well as treatments for pediatric patients with HIV. 

The first guidance, “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis” addresses the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection. The guidance provides sponsors with nonclinical and clinical recommendations specific to ...