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.

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FDA Draft Guidance for In Vitro Diagnostic Multivariate Index Assays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