To ensure a single, consistent method of advising drug companies about the status of applications, the FDA is proposing to change the terminology associated with its response letters.
The agency wants to replace "approvable letters" and "not-approvable letters" with "complete response letters" that would provide companies with specific information about what needs to be done before their drugs can be approved for marketing. That approach, currently used for biological drugs, would apply to all new drugs and generics, the FDA said.
As part of the changes, the new rule would amend provisions related to extending the review cycle on unapproved applications and resubmissions under complete response letters.
Under existing regulations, a resubmission extends the review period following receipt of an approvable or not-approvable letter.
But under the new proposal, responses to complete response letters for new drug applications would be classified by what needs to be done to obtain marketing approval.
A Class 1 resubmission would be defined as an application resubmitted after receipt of a complete response letter that includes only certain items, such as draft or final printed labeling, safety or stability updates, or other minor clarifying information. A Class 1 resubmission would start a new two-month review cycle.
Meanwhile, a Class 2 resubmission would be one that would require information beyond that called for in a Class 1 resubmission (for instance, information that would need to be presented at a public advisory committee meeting). A Class 2 resubmission would start a new six-month review cycle.
Also, the agency's proposal would retain the current "major" and "minor" terminology for resubmissions of generic drug applications. Under the proposal, a major generic drug marketing application resubmission would start a new six-month review cycle. A minor generic drug application resubmission would start a new cycle of 30 days to a few months, depending on the issues involved, the agency said.
The FDA will be accepting comments on the proposed rule until Oct. 18. Additional information can be obtained by visiting the federal register online at www.fda.gov/OHRMS/DOCKETS/98fr/04n-0267-npr0001.pdf or the FDA's website at www.fda.gov.
Agency Opens Cancer Office
The FDA has consolidated three areas within the Center for Drug Evaluation and Research (CDER) that are responsible for the review of drugs and therapeutic biologics used to diagnose, treat and prevent cancer, to create the Office of Oncology Drug Products.
Also, the office will control drugs and certain therapeutic biologics used in medical imaging, many of which are used to detect, treat or monitor cancer, the agency said. Work with recombinant therapeutic proteins and monoclonal antibodies will be included in the new office as well.
FDA officials believe the oncology office will help improve the consistency of review and policy regarding oncology drugs, and bring together a critical mass of oncologists who will help develop new therapies. That office also will provide technical consultation between CDER and other FDA components, including FDA's Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Food Safety and Applied Nutrition.
A national search to recruit a director for the new office will begin later this summer. The final implementation of the new structure will occur when the drug review staff from CDER moves to the new FDA White Oak, Md.-based facility, which is scheduled to begin in April.