What Not To Do When An FDA Inspector Knocks At Your Door
This article was originally published in The Tan Sheet
Executive Summary
FDA tweaks its guidance on what constitutes interference with inspections to include examples of “reasonable” explanations for delays. But industry requested other changes, including a formal process for notifying a firm of FDA’s intent to deem products adulterated due to delaying, limiting or refusing an inspection.
You may also be interested in...
Rx Companies Push For Exemptions To Breadth Of FDA Inspections
Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.
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.