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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 P060008
Most Recent Protocol Version Approved 10/10/2008
Study Name TAXUS Registry
Study Status Progress Inadequate
Study Progress Reason Follow-up rate below 80%
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center study designed to observe clinical outcomes in patients receiving the   show the rest ...
Study Population Description This device is indicated for improving luminal diameter for the treatment of de novo lesions   show the rest ...
Sample Size 4,200 consecutive patients, 100 sites
Data Collection The primary endpoint is the rate of cardiac death or myocardial infarction at 12 months.
Followup Visits and Length of Followup Patients will be followed annually to five years. Clinical follow-up will occur at 15, 24,   show the rest ...


TAXUS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
Summary Report 01/26/2009 01/26/2009 On Time
February Summary Report 03/30/2009 03/30/2009 On Time
April Summary Report 05/01/2009 05/01/2009 On Time
May 2009 Summary Report 05/29/2009 05/28/2009 On Time
June Summary Report 07/02/2009 07/02/2009 On Time
July Summary Report 08/04/2009 08/04/2009 On Time
August Summary Report 09/01/2009 09/01/2009 On Time
Sept Safety Report 10/07/2009 10/07/2009 On Time
Safety Report 11/03/2009 11/03/2009 On Time
Dec Safety Report 12/09/2009 12/04/2009 On Time
Jan Summary Report 01/07/2010 01/07/2010  
6 mth report 06/29/2010 06/29/2010 On Time
1 year report 12/29/2010 12/29/2010 On Time
18 month report 06/29/2011 06/29/2011 On Time
2 year report 12/29/2011 12/27/2011 On Time
3 year report 12/29/2012 12/26/2012 On Time
4 year report 12/29/2013 02/04/2014 Overdue/Received
5 year report 12/29/2014    
6 year report 12/29/2015    

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