What is CRL – Complete Response Letter by USFDA?

Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons.

CRL contains

• Description of specific deficiencies.
• Complete review of data.
• In case of Inadequate data, they highlights inadequacy.
• They also mention recommended action for approval.