What Not To Do When An FDA Inspector Knocks At Your Door
This article was originally published in The Tan Sheet
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...
A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant 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.
The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab.