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Post-Approval Studies

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.

Source: OpenFDATest

Data and Resources

FieldValue
Publisher
Modified
2013-11-01
Release Date
2013-11-01
Homepage URL
Identifier
910c9a83-0447-4c05-b418-c2f49dd83b1b
License
License Not Specified
Contact Name
openFDA
Contact Email
Public Access Level
Public
Harvested from OpenFDATest
Harvest Source TitleOpenFDATest
Harvest Source URIhttps://open.fda.gov/data.json
Last Harvest PerformedThu, 01/10/2019 - 00:04