Post-Approval Studies

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

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• IRB Letter from Dr. Schultz (dated 2/9/09)

Contact Information

Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002

Phone: (301) 796-6062
Fax: (301) 847-8140
nicole.jones@fda.hhs.gov

Show All Studies Export to Excel Application Number Post-Approval Study Commitment Study Name Protocol Approved Study Population Study Status P050052 PROVIDE THE RESULTS OF AN OPEN-LABEL, POSTAPPROVAL STUDY IN 100 PATIENTS WITH FITZPATRICK SKIN TYPES 4,5 OR 6 FROM FIVE OR MORE U.S. CENTERS WHO HAVE ELECTED TO UNDERGO NASO-LABIAL FOLD TREATMENT WITH SUBDERAL INJECTION OF RADIESSE. PATIENTS WILL BE FOLLOWED FOR A MINIMUM OF 24 WEEKS WITH VISITS FOR ASSESSMENT OF DERMAL PIGMENTATION AND KELOID CHANGES AT THE SITE OF INJECTION AT EACH FOLLOW-UP POINT POST-OPTIMAL COSMESIS. THE PURPOSE OF THE STUDY IS TO ASSESS THE LIKELIHOOD OF HYPERTROPHIC SCARRING AND KELOID FORMATION, IN PATIENTS WITH FITZPATRICK SCALE SKIN TYPES 4, 5 AND 6. SAFETY ENDPOINT ASSESSMENTS OF THIS STUDY ARE: 1) HYPERTROPHIC SCARRING OR KELOID FORMATION AT THE SITE OF INJECTION AT 12 AND 24 WEEKS; 2) PIGMENTATION CHANGES AT THE SITE OF INJECTION COMPARED TO ADJACENT SKIN AND; 3) ADVERSE EXPERIENCE ASSESSMENT. STUDY ENROLLMENT WILL BEGIN WITHIN 18 MONTHS OF THE APROVAL DATE; AND A FINAL REPORT WILL BE SUBMITTED WITHIN 2.5 YEARS OF THE APPROVAL DATE. ADDITIONALLY, POSTAPPROVAL REPORTS FOR THIS STUDY WILL BE SUBMITTED ANNUALLY INDEPENDENTLY OF OTHER REPORTS. PROVIDE THE RESULTS OF AN OPEN LABEL POSTAPPROVAL STUTDY IN 100 PATIENTS TO COLLECT LONG-TERM SAFETY INFORMATION ON THE USE OF RADIESSE INJECTED INTO NASOLABIAL FOLDS AND THE EFFECT OF MULTIPLE INJECTIONS. THE STUDY WILL ENROLL 100 PATIENTS AND MONITOR THESE PATIENTS FOR 3 YEARS AFTER THE DATE OF THEIR FIRST TREATMENT WITH A LOST TO FOLLOW-UP THAT DOES NOT EXCEED 20% OF THE PATIENTS ENROLLED. A FINAL REPORT WILL BE SUBMITTED WITHIN 4 YEARS AFTER THE APPROVAL DATE. IN ADDITION, POST APPROVAL REPORTS FOR THIE STUDY WILL BE SUBMITTED ANNUALLY INDEPENDENTLHY OF OTHER REPORTS.   Long Term (Nasolabial Folds) 12/22/2006 Transitional Adolescent B: 18-21 yrs, Adult: >21 Completed Short Term (Fitzpatrick) 12/22/2006 Transitional Adolescent B: 18-21 yrs, Adult: >21 Completed

Long Term (Nasolabial Folds) Schedule

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