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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 P080032
Current Protocol Accepted 09/14/2010
Study Name New Patient Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
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   show the rest ...
Followup Visits and Length of Followup Up to 5 years from the end of last treatment.

Every 6 months between annul visits,   show the rest ...


New Patient Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    

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