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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-GEM21S Growth Factor

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Application Number P040013 S016/ PAS001
Current Plan Approved 12/06/2011
Study Name OSB Lead-GEM21S Growth Factor
General Study Protocol Parameters
Study Design Bench/Lab Study
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 2¢ªC - 8¢ªC (horizontal) will undergo stability testing.
Sample Size Horizontal testing will be performed on at least one production lot annually, and a sample of three production lots will be tested out to 48 months for informational purposes (the current shelf life for the syringe is 42 months).
Data Collection pH, bioassay, Chromatographic purity evaluation, Protein concentration by analysis using UV, HPLC purity evaluation, SDS Page purity evaluation, sterility evaluation, and bacterial endotoxin evaluation.
Follow-up Visits and Length of Follow-up The stability study will follow each lot for at least 42 months 2-8¢ªC. The first three production batches will be tested through 48 months at 2-8¢ªC.

Long-term temperature Stability testing will be performed at 3, 6, 9, 12, 18, 24, 42 and 48 months.

OSB Lead-GEM21S Growth Factor Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's 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/final report 05/26/2015 05/22/2015 On Time
Rqst to waive next report 06/22/2015 06/22/2015 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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