FDA’s Benefit/Risk Framework Will Focus On Communication, Not Quantification
This article was originally published in The Pink Sheet Daily
Executive Summary
CDER Director Woodcock tells BIO’s International Conference that the agency’s effort to formalize its approach to risk/benefit assessments will produce better sharing of approval conundrums, but not necessarily a mathematical solution to those problems.
You may also be interested in...
Benefit-Risk Assessment Framework Moves Toward Global Harmonization
PhRMA shifts further development of its structured benefit-risk assessment framework to the European organization CIRS, which has relationships with regulators in Europe, the U.S. and elsewhere that can drive the framework’s adoption for the drug approval process.
What Does A Typical Refuse-To-File Letter Look Like?
Our infographic offers a composite sketch from a decade of US FDA data on refuse-to-file letters.
Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload
Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: