New Guidance Documents on Pediatric HIV Infection and Clinical Trial Imaging Endpoint Process Standards

New Guidance Documents 1. Pediatric HIV Infection: Drug Development for Treatment - Guidance for Industry FDA is announcing the availability of a draft guidance for industry entitled “Pediatric HIV Infection: Drug Development for Treatment.”  This draft guidance provides general recommendations on the development of products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth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.  2. Clinical Trial Imaging Endpoint Process Standards - Guidance for Industry The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that we regard as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint.