CORRECTED DATE: FDA Announces Draft Guidance on Developing Anti-infective Drugs for the Pediatric Population

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-anti-infective-drug-products-pediatric-population?utm_campaign=SBIA%3A%20Correction%20FDA%20ANNOUNCES%20DRAFT%20GUIDANCE%20ON%20DEVELOPING%20ANTI-INFECTIVE%20DRUGS&utm_medium=email&utm_source=Eloqua


FDA Announces Draft Guidance on Developing Anti-infective Drugs for the Pediatric Population

This message is being redistributed with the corrected date for submitting comments. 

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled Development of Anti-Infective Drug Products for the Pediatric Population. This guidance provides general recommendations on the development of anti-infective medicines for pediatric patients. The guidance addresses the timing of initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.

It is important to conduct clinical studies of anti-infective drugs in the pediatric population to assess safety and to inform dosing and assessment of efficacy. There are specific challenges with pediatric drug development that do not always apply to drug development for adult populations.

The FDA seeks comments and suggestions on this guidance by August 29th, 2020. For more information, please refer to the guidance.