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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-New Patient Study


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General
Application Number P080032 / PAS002
Current Plan Approved 09/14/2010
Study Name OSB Lead-New Patient Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center, single-arm study conducted in the United States and Canada
Study Population Description Adults (18-65 years) with asthms
Sample Size Enroll up to 300 adult subjects (a minimum of 250 subjects)
Data Collection The primary endpoint is the proportion of subjects experiencing severe exacerbations during the subsequent 12-month periods (for Years 2, 3, 4, and 5) compared to the first 12-month proportion after the Alair treatment.
Follow-up Visits and Length of Follow-up Up to 5 years from the end of last treatment.

Every 6 months between annul visits, and annul visits at 1, 2, 3, 4, and 5 years from the end of last treatment.



OSB Lead-New Patient Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/26/2010 10/25/2010 On Time
case report forms 02/11/2011 02/11/2011 On Time
1 year report 04/27/2011 04/28/2011 Overdue/Received
18 month report 10/26/2011 10/25/2011 On Time
2 year report 04/26/2012 04/26/2012 On Time
3 year report 04/26/2013 04/26/2013 On Time
4 year report 04/26/2014 04/25/2014 On Time
5 year report 04/26/2015 04/24/2015 On Time
6 year report 04/26/2016 04/25/2016 On Time
7 year report 04/26/2017    


Contact Us

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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