“Approvable” and “not approvable” letters will be discontinued by the FDA when it reviews new drug applications and abbreviated new drug applications; instead, the agency will issue “complete response” letters to indicate that a review cycle is complete and that an application is not ready for approval. Biologics license application sponsors also will receive complete response letters, under newly established regulations. The changes implement the user-fee performance goals referenced in the Prescription Drug User Fee Amendments of 1997 and 2002.
SOURCE: FDA Order
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