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
2018
Long-Term Follow-Up After Administration of Human Gene Therapy Products
Oversight of Laboratory-Developed Tests (LDTs)
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
2015
Oversight of Laboratory-Developed Tests (LDTs)
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FDA Draft Guidance for In Vitro Diagnostic Multivariate Index Assays
Report on Realizing the Potential of Pharmacogenomics
2005
CLIA and Genetic Testing
FDA Pharmacogenomic Data Guidelines