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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 P010047 S010
Current Protocol Accepted 03/19/2012
Study Name NeoMend ProGel Pleural Air Leak Sealant
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Case Control Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
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 Prospective, observational cohort study with a ProGEL Sealant group and a comparison group of standard-of-care.   show the rest ...
Study Population Description 267 ProGEL Sealant + 133 Comparison Group. Subjects in the comparison group follow the current   show the rest ...
Sample Size 267 ProGEL Sealant + 133 Control
Data Collection Study Endpoints 1. Pneumothorax

2. Air leak, persistent

3. Air leak, late onset

4. Residual pleural space

5. Acute respiratory distress syndrome (ARDS)

6. Post-surgical renal abnormalities

7. Myocardial   show the rest ...
Followup Visits and Length of Followup 90 days


NeoMend ProGel Pleural Air Leak Sealant Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 06/20/2012 08/22/2012 Overdue/Received
one year report 01/13/2013 01/14/2013 Overdue/Received
two year report 01/13/2014 01/13/2014 On Time
three year report 01/13/2015    
four year report 01/13/2016    
five year report 01/13/2017    

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