Trusted Trader Program Pairs FDA With Customs To Expedite Imports
This article was originally published in The Tan Sheet
Executive Summary
The Trusted Trader program would create some incentives to companies willing to ensure their supply chains are secure, but is similar to a program FDA already has in place.
You may also be interested in...
FDA Envisions International Focus Groups Navigating Globalization Issues
FDA could help create several international coalitions to carry out the agency’s globalization plan, which could allow for issue-specific groups focused on individual pharmaceutical sectors.
Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.