FDA Committee Suggests Flexible Approach to Qualifying Data
The FDA should allow developers of new and generic drugs more flexibility when they submit model-informed data, an advisory committee said.
At a meeting in Washington, D.C., the FDA’s Advisory Committee on Pharmaceutical Science and Clinical Pharmacology said the agency should avoid rigid requirements for validating individual models and instead recommended that sponsors present their data in a timeline — illustrating the steps the company went through to reach its conclusion, including data-driven annotations, ideally backed up by peer-reviewed science.
A proposed workflow would include verifying the drug model in healthy adults, alongside the development of a physiological model for various disease stages. Both models should account for changes in drug absorption, distribution, metabolism and excretion before being used to predict effects in a specific population.