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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P100034
Current Protocol Accepted 02/09/2016
Study Name OSB Lead-New Enrollment Study for NovoTTF-100A
Study Status Revised/Replaced Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, non-randomized open-label concurrent control study of NovoTTF-100A in recurrent GBM   show the rest ...
Study Population Description The NovoTTF-100A System is intended as a treatment for adult

patients (22 years of age or   show the rest ...
Sample Size 30 centers in the US, EU and Israel. At least 15 centers in the


Test arm:   show the rest ...
Data Collection Primary

¿ Overall survival (months)


¿ Change in neuro-cognitive function from baseline based on the   show the rest ...
Followup Visits and Length of Followup ¿ Recruitment: 48 months

¿ Follow-up: 12 months from recruitment of last patient

¿ NovoTTF-100A treatment until   show the rest ...

OSB Lead-New Enrollment Study for NovoTTF-100A Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 10/07/2011 11/28/2011 Overdue/Received
one year report 04/07/2012 06/13/2012 Overdue/Received
18 month report 10/06/2012 10/26/2012 Overdue/Received
two year report 05/08/2013 05/02/2013 On Time
three year report 04/07/2014 08/08/2014 Overdue/Received
four year report 04/07/2015 04/20/2015 Overdue/Received

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