FDA Offers Draft Recommendations on Drug Development for Pediatric HIV Infection

Regulatory NewsRegulatory News | 11 May 2018 |  By 

The US Food and Drug Administration (FDA) drafted new recommendations to aid sponsors in the development of drugs intended for the treatment of pediatric human immunodeficiency virus (HIV) infections.
In a six-page document, FDA outlines a total of five “major considerations” that can be applied on a global scale. For example, FDA recommends that “pediatric formulation development should begin as soon as the adult dose is selected based on results from the phase 2 trial(s).”
Some antiretroviral drugs for HIV infection treatment fall outside of the scope of the draft guidance, but are addressed in a final guidance issued in November 2015.
In November 2017, FDA also finalized guidance—drafted in May 2016—clarifying certain regulatory policies on Phase II and Phase III clinical trial designs in developing HIV drugs for patients co-infected with Hepatitis C virus (HCV).
Pediatric HIV Infection: Drug Development for Treatment: Draft Guidance for Industry


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