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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
Most Recent Protocol Version Approved 07/27/2010
Study Name AIR2 - Extended Study
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Actual Number of Patients Enrolled 190
Actual Number of Sites Enrolled 30
Patient Followup Rate Follow-up rates were 95.2%, 87.4%, 85.3%, 83.7%, and 85.3% at years 1-5, respectively.
Final Safety Findings There were six safety endpoints evaluated after the Alair treatment, and they were acceptable at   show the rest ...
Final Effectiveness Findings The proportions of subjects (expressed in percentages)

experiencing one or more severe exacerbations in Years 1-5   show the rest ...
Study Strengths and Weaknesses The study cohort was originally randomized and treated. However, during the 5-year follow-up, it became   show the rest ...
Recommendations for Labeling Changes None


AIR2 - Extended Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
6 month report 10/26/2010 10/25/2010 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-FINAL 04/26/2013 04/26/2013 On Time

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