FDA Complete Response Letters

Summary

This practice note discusses best practices for pharmaceutical companies to respond to a complete response letter (CRL) issued by the Food and Drug Administration (FDA). The FDA issues CRLs to drug companies when it has decided not to approve or license a drug product for which a company has submitted a new drug application (NDA) or biologics license application (BLA). CRLs are material, reportable events for public companies, and potentially devastating for nonpublic companies that have staked their reputation on the FDA’s approval or licensing of a particular drug product. All pharmaceutical companies should be prepared to respond to a CRL, including engaging the FDA and resubmitting an NDA or BLA with the goal of securing FDA approval or licensing.