FDA Stresses Need for Progressive Approach to Drug Development Regulation
Faced with an evolving clinical research and drug development landscape that was accelerated dramatically by COVID-19, the FDA’s Office of New Drugs (OND) will continue to take a progressive, adaptive approach to drug regulation going forward and explore innovative trial designs, according to its yearly report.
“In this rapidly evolving landscape of drug development, drug regulation cannot be static, but also must progress to assure that we can apply our statutes and regulations to novel issues and challenges,” said Peter Stein, director of OND, in the report. “OND staff, working with many other CDER offices, must keep up with the evolving science, and find ways that novel challenges in drug regulation can be addressed.”
The report shares instances in which the office worked with stakeholders in 2021 to promote innovation in trial design. For example, several meetings on its Complex Innovative Trial Design program ultimately delivered guidance on trial designs for serious diseases, such as systemic lupus erythematosus. These designs included master protocols and platform trials, innovative approaches that can hasten trial operations, identify and disqualify multiple candidates and significantly cut down costs.
Long-term, OND said its goals are to approve more drugs for unmet needs, expand drug approvals to more indications/patient populations and get more drugs with favorable risk-benefit profiles to market.
Read the full report here: https://bit.ly/3PeR3Qi.