Update on CDRH Patient-Centered Initiatives
May 31, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Data Analysis
April 19, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Instrument Development
March 15, 2018
Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot program
February 27, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews
February 15, 2018
Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
December 12, 2017
A Case Study in How Patient Preference Information Contributes to Regulatory Decisions for Medical Devices
December 4, 2017
Patient values and P-Values: Exploring a new method for developing patient-centered clinical trials
November 17, 2017
Virtual Patient R Code Access and Use
May 18, 2017
Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
April 17, 2017
MDICx – Quality Metrics: Best Practices, Cases Examples and How Metrics Factor into the Case for Quality
April 6, 2017
MDICx: Draft Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
April 5, 2017
Survey of Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – Report from the MDIC Clinical Diagnostics Surrogate Samples Working Group
March 23, 2017
Making the Business Case for Quality – Reports from the MDIC Case for Quality Competencies Working group
February 14, 2017
Clinical Trial Quality by Design: Factors Critical to Quality
August 10, 2016
