Policy
Regulation
Background
The development of personalized medicine requires that regulatory bodies adopt some new approaches to product approval. This will entail new guidance about the processes for obtaining approval to commercialize new therapeutics, including when and under what circumstances the use of a new drug must be preceded and/or accompanied by the use of a diagnostic or screening test. These critical regulatory processes influence many stakeholder groups and require a high-level of engagement from conception through implementation.
The Coalition has been and remains committed to improving regulatory frameworks so that personalized medicine can advance.
2019
Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products
- PMC Comment Letter (PDF)
February 2019
2018
Long-Term Follow-Up After Administration of Human Gene Therapy Products
Oversight of Laboratory-Developed Tests (LDTs)
- PMC Comment Letter to Reps. Bucshon (R-IN) and Diana DeGette (D-CO) on the U.S. Food and Drug Administration's "Technical Assistance" on the Diagnostic Accuracy and Innovation Act (DAIA) (PDF)
August 2018
2017
EMA Concept Paper on Predictive Biomarker-Based Assay Development
Oversight of Laboratory-Developed Tests (LDTs)
2016
Codevelopment of Diagnostics and Drugs
Oversight of Next-Generation Sequencing Tests
- PMC Docket Submission to FDA on the Agency's Proposed Oversight Framework for Next-Generation Sequencing Tests (PDF)
October 2016 - » Download the Guidance Document: Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases
- » Download the Guidance Document: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics
2015
Oversight of Laboratory-Developed Tests (LDTs)
- PMC Docket Submission to FDA on the Agency's Proposed Laboratory-Developed Test (LDT) Regulation Framework (PDF)
February 2015 - PMC Public Statement on FDA's Proposed Laboratory-Developed Test (LDT) Regulation Framework Guidance Documents (PDF)
January 2015
2014
PMC New Drug Approval Analysis
2013
Pathways for Oversight of Diagnostics
2009
FDA Drug-Diagnostic Co-Development Concept Paper
2007
U.S. System of Oversight of Genetic Testing
FDA Draft Guidance for In Vitro Diagnostic Multivariate Index Assays
- PMC Comments on FDA Draft Guidance for In Vitro Diagnostic Multivariate Index Assays (PDF)
August 27, 2007