What is a PADE Inspection?
Postmarketing Adverse Drug Experience (PADE) Inspections monitor industry compliance with post-marketing safety laws and regulations for human drugs and therapeutic biologics. They ensure that accurate, reliable, and timely safety data are submitted correctly to FDA.
Why is it important?
FDA’s PADE inspections ensure adherence to FDA reporting obligations and verify compliance to newly revised guidelines, updated in October 2022.
In 2019, 44% of PADE inspections occurred at companies that had no prior PADE inspection- if you have a post-marketed product and have yet to undergo a PADE inspection, it’s very probable you will be inspected soon. Other common triggers for inspections are if your organization has recently experienced corporate changes, additions to marketed product portfolios (especially any novel therapy types) or if they’ve had not prior PADE Inspections.
What to expect?
The FDA conducts a complete assessment of procedures, systems, records, and processes involved in evaluating, reporting, and submitting adverse drug events.
What are the most Common PADE Inspectional Observations from issued FDA 483 Forms?
- Failure to develop written procedures for the surveillance, receipt, evaluation, and/or reporting of post-marketing adverse drug experiences (ADEs)
- Failure to report all ADEs that are both serious and unexpected to FDA within 15 calendar days of initial receipt of information
- Failure to promptly investigate all ADEs that are the subject of 15-day Alert reports and failure to submit follow-up reports within 15 calendar days of receipt of new information
- Failure to submit all quarterly and/or annual periodic ADEs reports (PADERs) within the required timeframe
- Failure to submit individual case safety reports for all serious and expected ADEs and all nonserious ADEs within the required timeframe
What steps can you take to ensure readiness?
Its important to establish a robust and compliant safety system early in Phase 2/3. As you near product launch, companies can build upon their existing processes to prepare for post-market activities and be inspection ready
Need support with your inspection readiness plan?
Partner with SSI to adhere to the newly revised PADE Inspection Manual and ensure “accurate, reliable, and timely” safety processes
In 2019, 44% of PADE inspections occurred at companies that had no prior PADE inspection- if you have a post-marketed product and have yet to undergo a PADE inspection, it’s very probable you will be inspected soon. Other common triggers for inspections are if your organization has recently experienced corporate changes, additions to marketed product portfolios (especially any novel therapy types) or if they’ve had not prior PADE Inspections.
As with any inspection readiness effort, it requires coordination, documentation and engagement of cross-functional team members to ensure compliance. Preparation for Inspection Readiness activities can occur especially in busy times of rapid change- usually in the 6-8 months leading up to and directly after product launch. Having a dedicated inspection readiness team will ensure that this remains a priority.
To make your Inspection Readiness efforts run smoothly, SSI has a toolkit and team of experienced subject matter experts that can work amongst your team to ensure you are prepared and ready for the FDA. Reach out or submit an inquiry.
To help you get started in preparing, here are some Dos & Donts PADE Inspection
