PADE Inspections: What You Need to Know & Why
The October 2022 updates to the Chapter 53 of the FDAs Post-marketing Adverse Drug Experience (PADE) Inspection Manual resulted in a few key changes. We’ve helped our clients prepare, oftentimes mobilizing not only within PV, but across cross-functional partners (ex. MedInfo, Quality, Marketing, Regulatory, & Legal). While PADE inspections build upon the successes (or shortcomings) … Read more