The technological boom in recent years has led to an explosion of biomarker and genetic mutation tests. This boom has raised issues regarding the conduct of FDA-regulated clinical investigations. In this paper, our authors discuss the roles of the FDA, the sponsor, and the IRB in determining if a biomarker test is considered FDA-regulated medical device research when it is conducted as part of a clinical investigation.
WCG Insights Home » Whitepapers » Under the Microscope - Biomarker and Diagnostic Tests as FDA-Regulated Devices
Error - something went wrong!
Most Recent Flipbooks
Not Like Everyone Else: Unique Challenges for Small Biopharma Companies
Solving the Problem of Clinical Research Enrollment
Six Practices of High Performing Clinical Research Sites
Looking Ahead to 2018: Insights into Clinical Research Trends from Our Experts
In this paper, WCG thought-leaders provide insights on what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.
Is It Gene Therapy? Debating a Controversial Definition
Pragmatic Clinical Trials: What You Need to Know
Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations
Gene Therapy & Immunotherapy Glossary, 2nd Edition
The Second Edition of WCG’s wildly popular Alphabetical Glossary of Terms in Gene Therapy and Immunotherapy.
Choosing the Right Solution: Improving the Site Feasibility Process
Investigational Drugs Outside of Clinical Trials - Understanding Expanded Access and Right-to-Try
Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution
Addressing the Challenges of Human Tissues and Cell Products Regulation
Subject Recruitment Materials: Understanding the Requirements for IRB Review
Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference
The 21st Century Cures Act: Implications for Human Subjects
Infectious Disease Challenge Studies: Ethical Issues in Causing Disease for Medical Knowledge
Reducing Study Team and Site Burden through an Integrated eClinical Platform Solution
Towards Total Quality Management in Human Research Protection Programs: IRB Administrative and Reviewer Activities
Five Essential Considerations For Efficient Site Contracts and Payments
Innovation in Investigator Site Contracting