NDA Actions

Once an approval, approvable, or non-approvable recommendation is reached by the reviewers and their supervisors, the decision must be evaluated and agreed to by the director of the applicable drug review division or office. For the director's review, the consumer safety officer assembles an "action package" that contains the action letter and any data, CDER reviews and memos, and other information supporting the reviewers' recommendation.

Following his/her review of the action package, the division director may begin a dialogue with the reviewers and their supervisors. The division director generally serves as the final FDA ruling. In this sense, the division director is said to have "sign-off" authority for such drugs. The level of "sign-off" authority needed is determined by the classification of the drug under consideration. Class 1 drugs, for example, cannot be "signed off" by division directors; they require office level "sign-off" on action letters.

Once the division director (or office director, as appropriate) signs an approval action letter, the product can be legally marketed starting that day in the United States.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.