News
Media
Conferences
Partners
Publications
Events
CME/CE
Resources
PBM Directory
Subscribe

Spotlight -

Predictions for 2026: Our January 2026 issue|

MHE State of the Industry survey|

AMCP Nexus 2025|

2025 Fall Clinical Dermatology|

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?

Newsletter

Get the latest industry news, event updates, and more from Managed healthcare Executive.

Related Content

2 experts are featured in this series

Practical Takeaways for Patients, Providers, and Payers

ByJulia Rotow, MD ,Ibiayi Dagogo-Jack, MD

December 22nd 2025

man applying hand cream | Image credit: Africa Studio - stock.adobe.com

Top 5 most-read stories out of the 2025 AAD annual meeting

ByLaura Joszt, MA

December 17th 2025

2 experts are featured in this series

Limitations of Current Evidence for BRAF V600E-Mutant Metastatic NSCLC and Cross-Trial Comparisons

ByJulia Rotow, MD ,Ibiayi Dagogo-Jack, MD

December 15th 2025

2 experts are featured in this series

CNS Disease Considerations and Implications for Treatment Selection for BRAF V600E-Mutant Metastatic NSCLC

ByJulia Rotow, MD ,Ibiayi Dagogo-Jack, MD

December 15th 2025

2 experts are featured in this series

Practical Monitoring Strategies and Early Treatment Assessments in Patients with BRAF V600E-Mutant Metastatic NSCLC

ByJulia Rotow, MD ,Ibiayi Dagogo-Jack, MD

December 8th 2025

Latest CME

Community Oncology Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | South Carolina

Community Oncology Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | South Carolina

Misty D. Shields, MD, PhD; Rujul Parikh, MD

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Kansas

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Kansas

Charu Aggarwal, MD, MPH, FASCO; Yifan Tu, MD, PhD

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Wyoming and Montana

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | Wyoming and Montana

Charu Aggarwal, MD, MPH, FASCO; Mo Ziari, MD

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | New Mexico

Personalized Management in NSCLC: Strategies for Early Detection, Molecular Testing, and Targeted Therapies | New Mexico

Zofia Piotrowska, MD, MHS; Shan Guo, MD

Community Oncology Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | North Carolina

Community Oncology Connections™: Optimizing SCLC Treatment Strategies and Managing Adverse Events Across Disease Stages | North Carolina

Misty D. Shields, MD, PhD; Michelle Ojemuyiwa, MD

A Breath of Strength: Managing Cancer Associated LEMS and Lung Cancer as One

A Breath of Strength: Managing Cancer Associated LEMS and Lung Cancer as One

Estelamari Rodriguez, MD, MPH; Millie Das, MD; Ruham Nasany, MD

Huntington Beach Symposia

In-Person + Virtual Event

Huntington Beach Symposia

February 19-21, 2026

Striking the Right Nerve: Managing Cancer Associated LEMS in Lung Cancer Patients

Striking the Right Nerve: Managing Cancer Associated LEMS in Lung Cancer Patients

Anne Chiang, MD, PhD; J. Douglas Miles, MD, PhD, FAAN; Suma Satti, MD

3rd Annual Hawaii Lung: A Multidisciplinary Case-Based Conference

3rd Annual Hawaii Lung: A Multidisciplinary Case-Based Conference

David R. Gandara, MD; Roy S. Herbst, MD, PhD; Heather A. Wakelee, MD, FASCO

Community Practice Connections™: Incorporating Recent Updates in the Treatment of Metastatic ALK-Positive NSCLC

Community Practice Connections™: Incorporating Recent Updates in the Treatment of Metastatic ALK-Positive NSCLC

Zofia Piotrowska, MD, MHS; Bruna Pellini, MD; Alice Shaw, MD, PhD

Virtual Testing Board: Digging Deeper on Your Testing Reports to Elevate Patient Outcomes in Advanced Non–Small Cell Lung Cancer

Virtual Testing Board: Digging Deeper on Your Testing Reports to Elevate Patient Outcomes in Advanced Non–Small Cell Lung Cancer

Stephen V. Liu, MD; Michelle Afkhami, MD; Ignacio I. Wistuba, MD; Helena Yu, MD

Mastering Advances in Managing Unresectable and Metastatic NSCLC—Immunotherapy, Targeted Therapies, and Emerging Strategies

Mastering Advances in Managing Unresectable and Metastatic NSCLC—Immunotherapy, Targeted Therapies, and Emerging Strategies

Marina Chiara Garassino, MD; Sarah Goldberg, MD, MPH; Biagio Ricciuti, MD, PhD

Cases & Conversations™: Expert Perspectives on Leveraging Recent Advances to Transform SCLC Treatment

Cases & Conversations™: Expert Perspectives on Leveraging Recent Advances to Transform SCLC Treatment

Jacob Sands, MD; Anne Chiang, MD, PhD; Alissa J. Cooper, MD

22nd Annual Winter Lung Cancer Conference®

22nd Annual Winter Lung Cancer Conference®

Julie Brahmer, MD; Rogerio C. Lilenbaum, MD, FACP, FASCO; Mark A. Socinski, MD

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Fred Hirsch, MD, PhD, FASCO; Andy Guinigundo, MSN, RN, CNP, ANP-BC, FAPO

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Show Me Your Care Plan!™ Insights for Oncology Nurses on Comprehensive SCLC Treatment and Care Strategies

Fred Hirsch, MD, PhD, FASCO; Andy Guinigundo, MSN, RN, CNP, ANP-BC, FAPO

(CME Credit) Advancing Outcomes in Limited-Stage Small Cell Lung Cancer: From Evidence to Practice

(CME Credit) Advancing Outcomes in Limited-Stage Small Cell Lung Cancer: From Evidence to Practice

Lauren Averett Byers, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS

Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation

Medical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 Dysregulation

Rebecca Heist, MD, MPH; Alex A. Adjei, MD, PhD, FACP; Sandip Patel, MD, FASCO; Jeremy Segal, MD, PhD

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

PER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging Strategies

Jonathan W. Goldman, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhD

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC

Tumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLC

Balazs Halmos, MD, MS; Enriqueta Felip, MD, PhD; Julia Rotow, MD

Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer

Medical Crossfire®: The Precision Path for HER2 and TROP2-Targeted Treatments in Non–Small Cell Lung Cancer

Benjamin P. Levy, MD; Ticiana Leal, MD; Aaron Lisberg, MD; Christine M. Lovly, MD, PhD, FASCO

Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?

Medical Crossfire®: DLL3-Driven Innovations in Small Cell Lung Cancer – How Do Experts Apply Pivotal Advances to Practice?

Jacob Sands, MD; Jennifer Carlisle, MD; Hossein Borghaei, DO, MS

Trending on Managed Healthcare Executive

PBM reform. It has finally happened

Express Scripts agrees to reforms in settlement with FTC

How “Modern” Enterprise Health Technology Allows Health Plans to Excel at Managed Care

The best (and worst) ranked states for women’s health

Many patients with advanced blood cancers delay hospice to keep access to blood transfusions