FDA rejects 'approvable,' 'not approvable' terms.

The Food and Drug Administration will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, the agency will issue a "complete response" letter at the end of the review period, the FDA has announced.

The change goes into effect on Aug. 11 for all drug applications, regardless of when they were submitted.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said in a written statement.

Currently, when assessing new drug and generic drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to the labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before approval.

A "complete response" letter, which will replace options 2 and 3, will be issued to inform the company that the review period for a drug is complete and that the application is not yet ready for approval, the statement said. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to prepare the application for approval.

The way that the FDA communicates its decisions to approve an application--option 1--will not change.

The move brings the process for communication about drug licensing applications in line with that of biologics, for which "complete response" letters have been used since 1998. The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications, the agency said.

Other changes included in the new FDA rule involve modifications to the schedule for reviewing amendments to licensing applications, classification of responses to a complete response letter, (i.e., resubmissions), time lines for submitting a response to a complete response letter and administrative actions for a failure to respond, and definition of an efficacy supplement.

BY MIRIAM E. TUCKER

Senior Writer