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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 P070004
Current Protocol Accepted 03/09/2012
Study Name Post-Approval Case-Control Studies (PACCS)
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Case Control 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 Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Five case-control studies will be conducted in Brazil for 5 rare disease outcomes: rare CTDs,   show the rest ...
Study Population Description The case-control studies will be conducted in metropolitan urban areas of Southern Brazil.

Sientra¿s Silicone   show the rest ...
Sample Size For each of the 5 case-control studies, 1,280 cases of women diagnosed with studied rare   show the rest ...
Data Collection During enrollment, each study participant will complete a self-administered questionnaire. Information obtained from both the   show the rest ...
Followup Visits and Length of Followup There is no follow-up for case-control studies


Post-Approval Case-Control Studies (PACCS) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
quarterly report 06/08/2012 06/08/2012 On Time
six month report 09/07/2012 09/07/2012 On Time
2nd quarterly report 12/09/2012 12/07/2012 On Time
one year report 03/09/2013 03/01/2013 On Time
15 month report 09/06/2013 06/05/2013 On Time
18 month report 09/07/2013 09/06/2013 On Time
two year report 03/09/2014 02/25/2014 On Time
three year report 03/09/2015    
four year report 03/08/2016    
five year report 03/08/2017    

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