Checklist: Interacting with FDA During Drug Review Process
By Jerry Chapman
Be prepared for your next drug review.
Know the Do’s and Don’ts.
Have this expert-approved checklist handy when it comes time to talk with the FDA.
Get your checklist!
Download the Special Report
What You Will Learn from This Report:
The first countrywide import alert issued by FDA
An inadequate deviation investigation
An inadequate product specifications and a product recall
Process validation issues at a CMO
A different perspective on process validation and the culpability of the quality unit
