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  • April 19, 2019

SILVER SPRING, MD—The FDA finalized two guidances that focus on HIV prevention and treatment. “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis” addresses the agency’s current thinking on the overall development program and clinical trial designs to support the development of pre-exposure prophylaxis (PrEP) medications, which are long-acting systemic drug products used to prevent sexually acquired HIV-1. This guidance includes nonclinical and clinical recommendations specific to the development of systemic drug products like PrEP. The final guidance “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment,” provides general recommendations on the development of antiretroviral drug products to treat pediatric patients with HIV infections. The guidance specifically addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug product development.
The agency also published two revised draft guidances on bioavailability and food effects on medicines, including recommendations on new drug development. “Bioavailability Studies Submitted in NDAs or INDs —General Considerations,” provides recommendations to sponsors submitting bioavailability information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. The draft guidance “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs, NDAs, and supplements to these applications.