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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.

Links

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General
Application Number P970003 S050
Most Recent Protocol Version Approved 07/15/2005
Study Name Dosing Study D-21
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a multicenter, randomized, double-blind comparison of VNS Therapy using output currents of   show the rest ...
Study Population Description The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for   show the rest ...
Sample Size Approximately 460 patients will be implanted with the VNS Therapy System at up to 30   show the rest ...
Data Collection The following effectiveness evaluations will be obtained at the intervals specified on the study procedures   show the rest ...
Followup Visits and Length of Followup During the treatment period, the investigator obtains the evaluations specified on the study procedures flow   show the rest ...
Final Study Results
Actual Number of Patients Enrolled 331
Actual Number of Sites Enrolled 29
Patient Followup Rate 95.8% at the end of the acute 22-week phase (primary endpoint)
Final Safety Findings AEs were relatively well tolerated, as suggested by the low rate of subjects discontinuing due   show the rest ...
Final Effectiveness Findings The study did not meet the primary effectiveness outcome. The mean IDS-C 30-item change from   show the rest ...
Study Strengths and Weaknesses The main study strength is the randomized nature of the design. A weakness is that   show the rest ...
Recommendations for Labeling Changes Labeling changes are recommended to incorporate in the labeling the results of the randomized dosing   show the rest ...


Dosing Study D-21 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month dosing study report 01/13/2006 01/12/2006 On Time
1 year dosing study report 07/15/2006 07/12/2006 On Time
18 month dosing report 01/13/2007 01/10/2007 On Time
2 year dosing report 07/15/2007 07/12/2007 On Time
30 month dosing report 02/01/2008 01/11/2008 On Time
3 year dosing report 08/01/2008 07/31/2008 On Time
42 month dosing report 02/06/2009 02/04/2009 On Time
4 year report 08/07/2009 08/05/2009 On Time
Final Report 01/11/2011 08/27/2010 On Time

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