Statements (53)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory document
|
| gptkbp:availableOn |
FDA website
|
| gptkbp:canBeDraft |
true
|
| gptkbp:canBeFinal |
true
|
| gptkbp:describes |
recommendations
policies procedures |
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Guidance Documents
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:mayBeSuperseded |
true
|
| gptkbp:mayBeWithdrawn |
true
|
| gptkbp:mayReferTo |
federal regulations
statutes previous guidance |
| gptkbp:notableRelease |
true
|
| gptkbp:notLegallyBinding |
true
|
| gptkbp:publicCommentPeriod |
true
|
| gptkbp:purpose |
provide FDA's current thinking on a topic
|
| gptkbp:relatedTo |
gptkb:legislation
clinical trials adverse event reporting biosimilars cosmetics dietary supplements enforcement actions good manufacturing practices labeling requirements orphan drugs postmarket surveillance risk management data integrity product recalls generics import and export electronic submissions good clinical practice compounding manufacturing standards quality systems safety reporting combination products product approval |
| gptkbp:subjectArea |
gptkb:food
biologics drugs medical devices tobacco products veterinary products |
| gptkbp:targetAudience |
gptkb:industry
public FDA staff |
| gptkbp:bfsParent |
gptkb:US_Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
6
|