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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 P030050 S002
Current Protocol Accepted 04/23/2014
Study Name Clinical PAS
Study Status Study Pending
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a 5-year prospective, open-label, multi-center study to be conducted inthe United States in   show the rest ...
Study Population Description Immuno-competent male or female subjects 18 to 75 years of age with NLF contour deficiencies   show the rest ...
Sample Size 863 SCULPTRA Aesthetic naive subjects (including at least 22 with Fitzpatrick skin type IV and

122   show the rest ...
Data Collection Primary Endpoints:



Safety and effectiveness will be evaluated following the initial treatment regimen of the nasolabial   show the rest ...
Followup Visits and Length of Followup 5 years

Following the initial treatment regimen of the nasolabial folds, subjects' safety will be evaluated   show the rest ...


Clinical PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 mth status report 01/28/2010 01/28/2010 On Time
12 month report 08/05/2010 07/28/2010 On Time
6 month report 12/20/2011 03/15/2012 Overdue/Received
12 month interim report 09/14/2012 09/12/2012 On Time
18 month report 03/15/2013 03/15/2013 On Time
two year report 09/14/2013 09/16/2013 Overdue/Received
six month report 10/30/2014 10/30/2014 On Time
one year report 04/23/2015    
18 month report 10/23/2015    

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