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

• PMC Comments on EMA Concept Paper on Predictive Biomarker-Based Assay Development in the Context of Drug Development and Lifecycle (PDF)
  November 2017
  
• » Concept Paper on Predictive Biomarker-Based Assay Development in the Context of Drug Development and Lifecycle
  

Oversight of Laboratory-Developed Tests (LDTs)

• PMC Comment Letter to Reps. Bucshon (RI) and Diana DeGette (D-CO) on the Diagnostic Accuracy and Innovation Act (PDF)
  July 2017
  
• » Summary: Diagnostic Accuracy and Innovation Act
  

2016

Codevelopment of Diagnostics and Drugs

• PMC Docket Submission to FDA on the Agency's Draft Guidance on the Codevelopment of Diagnostics and Drugs (PDF)
  October 2016
  
• » Download the Guidance Document: Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product
  

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
• » Download the Guidance Document: Framework for Regulatory Oversight of LDTs
• » Download the Guidance Document: FDA Notification and Medical Device Reporting for LDTs
  

2014

PMC New Drug Approval Analysis

• PMC Analysis: More Than 20 Percent of the Novel New Drugs Approved by FDA's Center for Drug Evaluation and Research (CDER) in 2014 are Personalized Medicines (PDF)
  January 2014
  

2013

Pathways for Oversight of Diagnostics

• PMC White Paper: Pathways for Oversight of Diagnostics (PDF)
  January 2013
  

2009

FDA Drug-Diagnostic Co-Development Concept Paper

• PMC Comments on FDA Drug-Diagnostic Co-Development Concept Paper (PDF)
  December 9, 2009
• » Download the Paper
  

2007

U.S. System of Oversight of Genetic Testing

• PMC Comments on Draft Report - U.S. System of Oversight of Genetic Testing (PDF)
  December 21, 2007
  
• » View the Final Report
  

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
• » Download the Guidance Document
  

Report on Realizing the Potential of Pharmacogenomics

• PMC Comments on Draft Report - Realizing the Potential of Pharmacogenomics (PDF)
  June 21, 2007
• » Download the Final Report
  

2005

CLIA and Genetic Testing

• PMC Policy Position: CLIA and Genetic Testing (PDF)
• PMC Policy Brief: CLIA and Genetic Testing (PDF)
  

FDA Pharmacogenomic Data Guidelines

• PMC Policy Position: FDA Pharmacogenomic Data Guidelines (PDF)
  March 2005