Approvable_letter
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.[1] The letters were intended to let manufacturers know how much work is needed on their applications.[1] Non-approval letters were rejections of a drug's application.[2] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110.[3]
In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval.[4][5]