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Postmarket Requirements and Commitments
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| description | Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct. |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "application/zip",
"downloadURL": "http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/UCM070783.zip"
}
]
|
| identifier | bf085673-ae08-4807-8ca7-aeb36dde83ed |
| issued | 2021-02-25 |
| keyword |
[
"cder",
"commitments",
"postmarket"
]
|
| landingPage | http://www.fda.gov/Drugs/InformationOnDrugs/ucm142931.htm |
| license | http://opendefinition.org/licenses/odc-odbl/ |
| modified | 2011-02-10 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Postmarket Requirements and Commitments |
