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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 P100014
Current Protocol Accepted 02/26/2014
Study Name Solesta - Long Term Study
Study Status Progress Adequate
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 No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, single-arm, multicenter, observational clinical study.
Study Population Description Adults 18-75 years old with FI who have failed conservative therapy.
Sample Size It is anticipated that at least 244 patients and as many as 293 patients may   show the rest ...
Data Collection The primary efficacy endpoint of this study is freedom from FI

reintervention.



The primary safety endpoint will   show the rest ...
Followup Visits and Length of Followup 36 months

3, 6, 12, 24 and 36 months


Solesta - Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
case report forms 10/27/2011 10/27/2011 On Time
six month report 11/25/2011 12/16/2011 Overdue/Received
one year report 05/26/2012 06/13/2012 Overdue/Received
18 month report 11/24/2012 01/22/2013 Overdue/Received
two year report 05/26/2013 06/19/2013 Overdue/Received
three year report 07/10/2014 07/10/2014 On Time
four year report 05/26/2015    
five year report 05/25/2016    

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