Today, the FDA published more than 200 decision letters, known as complete response letters or CRLs. CRLs are issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form. By making these CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.