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Opinion|Videos|August 9, 2024

Understanding Prescription Digital Therapeutics: Definition, FDA Review and Clinical Impact

Author(s)Arwen Podesta, MD

Arwen Podesta, MD, defines what prescription digital therapeutics (PDTs) are, describes how they differ from nonprescription digital health tools, and details the FDA review process for PDTs.

Episodes in this series

EP. 1 Understanding Prescription Digital Therapeutics: Definition, FDA Review and Clinical Impact

EP. 1 Understanding Prescription Digital Therapeutics: Definition, FDA Review and Clinical Impact

EP. 2 Promising Therapeutic Areas for PDTs and Addressing Unmet Needs in Mental Health

EP. 2 Promising Therapeutic Areas for PDTs and Addressing Unmet Needs in Mental Health

EP. 3 Benefits and Safety of PDTs

EP. 3 Benefits and Safety of PDTs

EP. 4 PDTs as a Part of Integrative Care and Evaluating Patient Outcomes With PDTs

EP. 4 PDTs as a Part of Integrative Care and Evaluating Patient Outcomes With PDTs

EP. 5 Communicating PDT Benefits to Patients and Clinician Training for Implementation

EP. 5 Communicating PDT Benefits to Patients and Clinician Training for Implementation

EP. 6 Successful PDT Implementation: Examples and Key Strategies

EP. 6 Successful PDT Implementation: Examples and Key Strategies

EP. 7 Managed Care Strategies for Ensuring Patient Access to PDTs

EP. 7 Managed Care Strategies for Ensuring Patient Access to PDTs

EP. 8 Managed Care Challenges and Solutions for PDT Coverage, and Evaluating Patient Outcomes and Satisfaction

EP. 8 Managed Care Challenges and Solutions for PDT Coverage, and Evaluating Patient Outcomes and Satisfaction

EP. 9 K-Cast Written Summary. Prescription Digital Therapeutics – Addressing Unmet Needs Among Patients With Mental Health Conditions

EP. 9 K-Cast Written Summary. Prescription Digital Therapeutics – Addressing Unmet Needs Among Patients With Mental Health Conditions

Can you define what prescription digital therapeutics (PDTs) are and describe how they differ from nonprescription digital health tools?

What is the FDA review process for PDTs, and how is it different from the review process for prescription drugs and medical devices? How does FDA authorization of a PDT factor into clinical decision-making about a treatment?

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