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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

Patients

Patients Clinic Medical Patient-Centered

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Primary Care Digest

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

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