PORTAL: Program on Regulation, Therapeutics, and Law
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  • About Us
    • What is PORTAL?
    • Core Faculty
    • Research Team
    • Affiliated Faculty & Researchers
    • Expert Roundtable
  • Our Work
    • Publications
    • Policy Action
    • Literature Scan
    • In the Press
    • Media Center
    • Teaching
    • CeBIL
    • Biomarkers >
      • About The Project
      • The PBRC Team
      • Our Collaborators
      • AERO Graph
      • Workshops
      • Biomarkers2018
    • FDA REMS
  • Blog
  • Events
    • #policyethx 2020-2021
    • Events Archive >
      • #policyethx 2019-2020
      • #policyethx 2018-2019
      • #policyethx 2017-2018
      • #policyethx 2016-2017
      • Biosimilar Insulin
      • Older Events
  • Join Us
    • PORTAL Fellowship
  • Contact
    • Inquiries
    • E-mail List

FDA REMS


About our study:

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We are a group of investigators at Harvard Medical School and Brigham and Women’s Hospital conducting research on Risk Evaluation and Mitigation Strategy (REMS) programs, which the Food and Drug Administration (FDA) requires the manufacturers of certain medications to implement. Our project team is seeking to better understand the benefits and burdens of REMS programs on patient care. Our work is being funded by the FDA and does not involve any pharmaceutical companies.
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Participation opportunities:

Xyrem or Xywav
(sodium oxybate)

Have you started taking Xyrem or Xywav (sodium oxybate) in the past 3 years? 
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If yes, we want to talk to you!

We would like to extend an invitation to individuals age 18 or above who started taking Xyrem or Xywav (sodium oxybate)—a REMS program-covered drug—in the past 3 years to participate in a 60-minute phone interview on their experiences. Participants will receive a $50 Amazon gift card as a token of appreciation.
 
If you meet the above criteria and are interested in participating in the study, please email 
asarpatwari@bwh.harvard.edu for more information.
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Study Team

  • ​Ameet Sarpatwari, PhD, JD 
  • Aaron S. Kesselheim MD, JD, MPH
  • Will Feldman, MD, DPhil
  • Mayookha (Tuli) Mitra-Majumdar, MPH
  • Beatrice Brown, MBE
  • Aviva Wang, MS
  • Heidi Zakoul, BA
  • ​Su Been Lee, BA

Contact Us

Principal Investigator
Ameet Sarpatwari, PhD, JD 
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Email: asarpatwari@bwh.harvard.edu
Phone: ​(617) 278-0930

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Program On Regulation, Therapeutics And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
1620 Tremont Street, Suite 3030
Boston, MA 02120
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