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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 P040013 S016
Current Protocol Accepted 12/06/2011
Study Name GEM21S Growth Factor
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Bench/Lab Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Stability testing (bench study)
Study Population Description GEM21S (Formulated rhPDGF-BB) 0.5 mL in a 1 mL syringe on Long Term Stability at   show the rest ...
Sample Size Horizontal testing will be performed on at least one production lot annually, and a sample   show the rest ...
Data Collection pH, bioassay, Chromatographic purity evaluation, Protein concentration by analysis using UV, HPLC purity evaluation, SDS   show the rest ...
Followup Visits and Length of Followup The stability study will follow each lot for at least 42 months 2-8¢ªC. The first   show the rest ...


GEM21S Growth Factor Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 11/25/2011 11/21/2011 On Time
one year report 05/26/2012 05/21/2012 On Time
18 month report 11/24/2012 11/19/2012 On Time
two year report 05/26/2013 06/05/2013 Overdue/Received
three year report 05/27/2014 05/23/2014 On Time
four year report 05/26/2015    
five year report 05/25/2016    

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