Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international guidance, as well as other FDA guidances. The groups also asked for more clarity on several aspects of the guidance.
In September, FDA published a revised draft guidance on pediatric studies that drug and biologic sponsors can use to support their products. Several stakeholders, including the drug industry group PhRMA and Biotechnology Innovation Organization (BIO), wrote to the agency with their recommendations. (RELATED: FDA drafts guidance on pediatric clinical pharmacology studies, Regulatory Focus 8 September 2022)
Both BIO and PhRMA asked FDA to align its guidance with international guidance, including ICH’s E11A guideline on pediatric extrapolation, which reached Step 2 of the ICH process earlier this year…
