FDA guidance

GPTKB entity

Statements (22)
Predicate Object
gptkbp:instanceOf 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 guidance document
https://www.w3.org/2000/01/rdf-schema#label FDA guidance
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