Remove 2022 Remove Biosimilars Remove Clinical Pharmacology Remove Pharmacokinetics
article thumbnail

What recent paediatric guidelines mean for drug developers 

Drug Discovery World

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

We have tried to sort guidance documents by topic area.

FDA 40