HealthEconomics.Com

Connected. Community.

  • facebook
  • linkedin
  • twitter
  • vimeo
  • rss
  • News
  • Jobs
    • HE Jobs Portal
    • View all Jobs
    • Post a Job
  • Value, Evidence and Access Marketplace
    • Visite the Marketplace
    • On-demand Webinar
  • Industry Events
    • HealthEconomics.Com Webinars
    • View Conferences
    • View Webinars
  • Newsletters
    • Subscribe
    • View All
  • Blog
  • Resources
    • Value Communication
    • Free Marketing Consultation!
    • The Future of Print Medical Journals: How to Stay Relevant
    • Be a Better Writer
    • White Papers
    • Education Resources
    • Syndicated Reports
    • Books
    • Databases
    • Blogs
      • HE-Artists
      • Podcasts
  • HE Institute
You are here: Home / HEOR Feature / Aetion analyzes RWE impact in 4 recent FDA decisions in infectious disease

Aetion analyzes RWE impact in 4 recent FDA decisions in infectious disease

Senior Directors from Aetion (Purpura and Harvey) analyzed four approvals for products intended to treat or prevent infectious diseases from 2019 that included RWE studies to highlight how foreign postmarketing data improves understanding of a product’s risk-benefit profile. The products examined included: DENGVAXIA® (Dengue Tetravalent Vaccine, Live), EGATEN™ (triclabendazole), JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Non-Replicating), and RECARBRIO™ (imipenem, cilastatin, and relebactam).

The authors conclude that these four cases demonstrate how RWE is used for label expansion and post-approval safety reporting, and underscore how real world data, when fit for purpose, has been used to generate evidence to support product approval. FDA Commissioner Stephen Hahn, M.D., stated, “The more experience we have with real-world evidence, the more confidence we will have in using it for product decisions.”

Read more.

(Source:  Purpua C, Harvey R. Aetion, July 30, 2020)



You might also be interested in:

  • New Program in Pharmaceutical Value Assessment and… 01/22/2021
  • Join Aetion’s science leaders for a Q&A during ICPE All Access 09/21/2020
  • Trump's "Buy American" Executive Order Could Raise Drug Prices 08/06/2020
  • Key Innovations Coming From The Next Generation of PBM’s 08/12/2020
  • Scientist.com to Acquire HealthEconomics.Com, the World’s… 12/15/2020
  • AHRQ’s Registries User Guide Gets A New Edition 09/24/2020
  • What Are The Recent Top 4 Innovative Consolidations and… 08/26/2020

 

View All JobsPost a JobView Current NewsletterSubscribe to Newsletters
Conference of the Week:

Link of the Week:

Job of the Week:

Webinar of the Week:

White Papers

  • Whitepaper: The Role of Centralized Care Management in Value-based Care
  • 2017 In-Depth Outlook on Oncology Report
  • Value-Based Healthcare: Making it Happen
  • Value-Based Contracting for Biopharmaceuticals Moves Forward
  • ICER Releases White Paper on Gene Therapy

Syndicated Reports

  • HTA in Europe: Key Success Factors for Positive HTA Recommendations
  • Paying for Digital Health: Payer Insights
  • Benchmarking Pharma’s MSL Capabilities
  • Biosimilars: US Payer Perspectives
  • KAM Metrics: Driving Efficiency, Measuring Success
HealthEconomics.Com

HealthEconomics.Com

  • News
  • Conferences
  • Reports
  • Jobs
  • Consulting
  • Newsletters
  • White Papers

More Links

  • Jobs
  • Education
  • Graduate Schools
  • Webinar Services

Support & Contact

  • Contact Us

About

  • About Us
  • Advertise
  • Webinar Services
  • HE Institute
  • Testimonials
  • Privacy Policy

Stay Connected

  • facebook
  • twitter
  • linkedin
  • pinterest
  • google-plus
  • youtube
  • rss

HealthEconomics.Com is the world’s most comprehensive and credible CONNECTED COMMUNITYTM that serves as the global link to the health economics & outcomes research (HEOR) and pharma market access stakeholder communities.

HEALTHECONOMICS HZ SMALL V2

HE Institute

Strategy, Training, Education, and Communications in HEOR & Market Access.

Innovation Webinar

Big ideas accelerating change in HEOR, RWE and Health Technology. Learn more!

tHEORetically Speaking Blog

Insights and observations for HEOR, market access, pricing, reimbursement, and health policy.

HE Jobs Portal

Your Premier Employment Source for HEOR, Market Access, and Real World Evidence

HE Webinars

Online educational and informational seminars for HEOR, market access, pricing, and reimbursement.
  • HealthEconomics.Com
  • About HealthEconomics.Com
  • Advertising Inquiries
  • Careers
  • Contact HealthEconomics.Com

HealthEconomics.Com is the world’s most comprehensive and credible CONNECTED COMMUNITYTM that serves as the global link to the health economics & outcomes research (HEOR) and pharma market access stakeholder communities, proving news, education, jobs, resources, policy updates, consulting, advertising, all available via website, newsletters, and social media.

© 2017 Health Economics. All rights reserved.

  • News
  • Jobs
    • HE Jobs Portal
    • View all Jobs
    • Post a Job
  • Value, Evidence and Access Marketplace
    • Visite the Marketplace
    • On-demand Webinar
  • Industry Events
    • HealthEconomics.Com Webinars
    • View Conferences
    • View Webinars
  • Newsletters
    • Subscribe
    • View All
  • Blog
  • Resources
    • Value Communication
    • Free Marketing Consultation!
    • The Future of Print Medical Journals: How to Stay Relevant
    • Be a Better Writer
    • White Papers
    • Education Resources
    • Syndicated Reports
    • Books
    • Databases
    • Blogs
      • HE-Artists
      • Podcasts
  • HE Institute