Updated FDA Guidance to Industry

Revised FDA Guidance to Industry on Pediatric ARV Development based on its Vatican commitment in 2017.

Outcome document with 2018 commitments on paediatric diagnostics and treatment

UNAIDS October 2018 update action 35

UNAIDS October 2018  update on Action 35

Rome Action Plan – Status Report

The adoption of the Rome Action Plan has made possible some solid progress in the area of paediatric HIV.

Synergy Meeting Report

WHO organized a synergy meeting with key stakeholders in diagnostics to find concrete ways on how
to improve and increase access to high quality diagnostics and understand the key activities of Unitaid grantees
and other key stakeholders to discuss and determine how they can be translated into public health policy and
ultimately have global patient impact.

PEPFAR Technical Consultation on Pediatric Case Finding

On February 9, 2018, over fifty technical experts gathered to address challenges in pediatric HIV case finding, and specifically identification of pre-adolescent children with HIV before they present to facilities with illness. This remains a significant issue for all implementing partners.

Rome Action Plan

On 17 November 2017, leaders of major pharmaceutical and medical technology companies, multilateral organizations, donors, governments, organizations providing or supporting services for children living with HIV, and other key stakeholders participated in a High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents.

FDA Letter to PEPFAR

Letter from the Center for Drug Evaluation and Research, U.S. Food and Drug Administration to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR)

Global Accelerator for Paediatric Formulations (GAP-f)

Update on the development of the Global Accelerator for Paediatric Formulations (GAP-f).

Paediatric ARV Drug Optimization 3 Review

The Paediatric ARV Drug Optimization (PADO) group re-convened at the end of 2017 to review the implementation of the PADO3 list and discuss key technical elements to advance drug optimization for infants, children and adolescents in the context of future antiretroviral (ARV) guidelines revision. This is a summary of the outcomes of the discussion that took place via teleconference on December 12th 2017.