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Statements

Subject Item
dbr:Approvable_letter
rdfs:label
Approvable letter
rdfs:comment
Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110.
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dbc:Food_and_Drug_Administration
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dbr:Pharmaceutical_industry dbc:Food_and_Drug_Administration dbr:Complete_Response_Letter dbr:Food_and_Drug_Administration dbr:Title_21_of_the_Code_of_Federal_Regulations dbr:Medication
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Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110. In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval.
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