ICH: BIO Submits Comments on S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
April 1, 2019
BIO submitted comments to the Food and Drug Administration (FDA) on the draft guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines.
BIO's comments address the use of datasets, in vitro nonclinical investigations, and the necessity of repeating juvenile toxicity studies on a prodrug of an approved drug when there may or may not be existing adult toxicity data for the prodrug.
Download Full Comments Below
BIO Comments On S11 Nonclinical Safety Testing In Support Of Development Of Pediatric Medicines FDA-2018-D-4524
In advance of the Agency's public workshop on Enhancing Adoption of Innovative Clinical Trial Approaches, BIO outlined specific considerations and plans to participate in the workshop.
BIO submitted comments to the Food and Drug Administration (FDA) on the draft guidance, S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines.
BIO's comments address the use of datasets, in vitro nonclinical investigations, and the necessity of repeating juvenile toxicity studies on a prodrug of an approved drug when there may or may not be existing adult toxicity data for the prodrug.