Pediatric HIV Infection: Drug Development for Treatment Guidance for Industry

Pediatric HIV Infection: Drug Development for Treatment Guidance for Industry





FDA is announcing the availability of a draft guidance for industry entitled “Pediatric HIV Infection: Drug Development for Treatment.” This draft guidance provides general recommendations on the development of products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age), including recommendations on when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection.