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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 P040001
Most Recent Protocol Version Approved 12/08/2006
Study Name COAST Study
Study Status Progress Inadequate
Study Progress Reason Subject enrollment milestones not met
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 Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The COAST is a multi-center prospective study that will evaluate the safety and effectiveness of   show the rest ...
Study Population Description The study population is comprised of patients aged 50 years and older who have lumbar   show the rest ...
Sample Size The sample size is 240 patients
Data Collection Office visits are scheduled preoperatively, and at 6 weeks and 1, 2, 3, 4, and   show the rest ...
Followup Visits and Length of Followup Safety and effectiveness data are assessed at baseline and annually through 5 years postoperatively. The   show the rest ...


COAST Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
18 month report 05/20/2008 05/20/2008 On Time
3 year report 11/20/2008 11/20/2008 On Time
4 year report 11/20/2009 11/13/2009 On Time
5 year report 11/20/2010 09/03/2010 On Time
6 year report 11/20/2011 11/12/2010 On Time
interim report 11/20/2011 11/18/2011 On Time
7 year report 11/21/2012 11/13/2012 On Time
reporting changes 01/29/2013 01/29/2013 On Time
8 year report 11/20/2013 11/21/2013 Overdue/Received

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