Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:regulatory_document
|
| gptkbp:appliesTo |
gptkb:food
biologics cosmetics drugs medical devices tobacco products |
| gptkbp:example |
gptkb:ANDA_Submissions_guidance
gptkb:Good_Clinical_Practice_guidance Data Integrity guidance Labeling guidance |
| gptkbp:format |
gptkb:guidance_document
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:may_be_revised |
true
|
| gptkbp:not_legally_binding |
true
|
| gptkbp:public_comment_period |
true
|
| gptkbp:publishedIn |
FDA website
|
| gptkbp:purpose |
clarify regulatory requirements
provide recommendations to industry |
| gptkbp:bfsParent |
gptkb:IEC_62304
|
| gptkbp:bfsLayer |
6
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA guidance
|