New Market Study, "Complete Response Letter Trends and Approval Strategies", Has Been Published
A Complete Response Letter (CRL) describes deficiencies in an NDA/BLA submission that prevent the FDA from approving the application in its original form. Where possible, the CRL will make recommendations for corrective action that the applicant should take. Receipt of a CRL slows approval, causing increased costs and lost sales, and may even prompt withdrawal of the application.
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