• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies

  • Print
  • Share
  • E-mail

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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

Show All Studies
Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
Application Number P090016
Current Protocol Accepted 05/01/2012
Study Name Belotero Balance PAS
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Actual Number of Patients Enrolled 117 adults
Actual Number of Sites Enrolled 9
Patient Followup Rate 97% (113/117)
Final Safety Findings Re-treatment with Belotero Balance did not result in an increase in ¿severe¿ adverse events (AEs).   show the rest ...
Final Effectiveness Findings No effectiveness endpoints were included in the study.
Study Strengths and Weaknesses The post-approval study sample size was 117 exceeding the minimum requirement of 104 subjects. A   show the rest ...
Recommendations for Labeling Changes Labeling changes are recommended to reflect severe adverse event incidence rates after re- treatment.   show the rest ...

Belotero Balance PAS Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
six month report 05/14/2012 06/18/2012 Overdue/Received
one year report 11/13/2012 11/06/2012 On Time
18-month report-FINAL REPORT 05/14/2013 03/18/2013 On Time

Show All Studies