Statements (28)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
|
| gptkbp:appliesTo |
biologics
cosmetics medical devices food industry pharmaceutical industry |
| gptkbp:basisFor |
gptkb:legislation
|
| gptkbp:enforcedBy |
gptkb:FDA_Office_of_Regulatory_Affairs
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Guidelines
|
| gptkbp:includes |
gptkb:Good_Clinical_Practice_(GCP)
gptkb:Good_Laboratory_Practice_(GLP) gptkb:Good_Manufacturing_Practice_(GMP) adverse event reporting labeling requirements clinical trial requirements post-market surveillance product approval process |
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:publishedIn |
FDA website
|
| gptkbp:purpose |
protect public health
ensure safety and efficacy |
| gptkbp:updated |
periodically
|
| gptkbp:usedBy |
manufacturers
healthcare professionals clinical researchers regulatory affairs specialists |
| gptkbp:bfsParent |
gptkb:Sequential_Medical_Trials
|
| gptkbp:bfsLayer |
5
|