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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

Show All Studies
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General
Application Number P040024
Current Protocol Accepted 03/25/2005
Study Name Restylane
Study Status Completed
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study was a prospective, randomized, comparative, efficacy evaluator-blinded, design. Subjects meeting the enrollment criteria   show the rest ...
Study Population Description This device is indicated for mid-to-deep dermal implantation for the correction of moderate to severe   show the rest ...
Sample Size 150 patients from 10 or more centers
Data Collection Assessments include pain, tenderness, redness, ecchymosis, swelling. itching, mass (nodule / cyst / abscess) formation,   show the rest ...
Followup Visits and Length of Followup Screen/Baseline, 72 hours, 2 weeks, 6 weeks, 12 weeks and 24 weeks
Final Study Results
Actual Number of Patients Enrolled 150 subjects were randomized and treated. 148 subjects completed 24 weeks of follow-up and skin   show the rest ...
Actual Number of Sites Enrolled 9
Patient Followup Rate 98.70%
Final Safety Findings Based on skin testing, antibody data and histopathology, neither Restylane nor Perlane are immunogenic. There   show the rest ...
Study Strengths and Weaknesses One of the study strengths is the randomized study design, which allows for control of   show the rest ...
Recommendations for Labeling Changes Amend the label with a summary of the postapproval study and findings regarding assessing the   show the rest ...


Restylane Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 09/23/2005 10/11/2005 Overdue/Received
1 year report 04/25/2006 03/15/2006 On Time
FINAL REPORT 08/15/2006 08/07/2006 On Time

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