The Food and Drug Administration proposed to change its review processes and timelines for both new and generic drug applications to “ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.”Under the proposed rule, the regulatory agency would issue “complete response letters” to drug firms instead of the “approvable” and “not approvable” letters currently sent. The FDA would send the complete response letter if the agency determines that it will not approve a New Drug Application or Abbreviated New Drug Application in its present form. The letter would describe all of the specific deficiencies and, where appropriate, explain the conditions necessary for the application to be approved. This new process, which is already being utilized by the agency for biological drugs, would be formalized for all drugs under the proposal. Additionally, the proposed rule would amend current provisions regarding review cycles after application resubmissions, supplements or amendments. The review period following resubmissions of efficacy supplements to NDAs would depend on the class of the resubmission. A Class 1 resubmission, which would begin a new two-month review cycle, would be defined as a resubmission after receipt of a complete response letter that includes items like draft or final printed labeling, safety or stability updates or other minor clarifying information. A Class 2 resubmission would require additional information beyond that necessary for a Class 1 resubmission and would initiate a new six-month review cycle.
