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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
Re-treatment with Belotero Balance did not result in an increase in ¿severe¿ adverse events (AEs).
Total percentage subjects with severe ¿common¿ AEs was 15.6% after the initial treatment, during the pre-approval study, and 7.7% with re-treatment during the post-approval study (p<0.0085). Specifically, the incidence rates of severe adverse events after re-treatment were 11.5% and 5.4% for subjects with Fitzpatrick Skin Type Grades I-III and Grades IV-VI respectively. The duration of ¿severe¿ adverse events with re-treatment was generally short (mean 10.2 days, SD = 5.6, 95% CI = 8.2, 12.2) and none of these events required treatment.
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
total of 113 re-treated subjects completed the study achieving a 97% follow-up rate. Adverse events occurring beyond one month after re-treatment were not captured because the length of follow-up was restricted to one month.
Recommendations for Labeling Changes
Labeling changes are recommended to reflect severe adverse event incidence rates after re- treatment.