Last-minute labeling negotiations are not an appropriate time for presentation of additional data by NDA sponsors, FDA said in a draft guidance on review practices.

"Since the labeling discussions occur near the end of the review cycle, it is important that applicants not submit large amounts of new data to the review division in support of proposed labeling text," the draft "Guidance for Reviewers and Industry on Good Review Management Principles for Prescription Drug User Fee Act Products" states.

The ¹ draft guidance, scheduled to be announced in the July 28 Federal Register, outlines best practices for ensuring an efficient and, if possible, one-cycle review process for NDAs.

Recommendations include beginning label negotiations, which can typically hold up final approval, early in the application process.

The draft suggests that review teams hold internal labeling meetings in advance of the user fee date and communicate potential labeling issues to the applicant. The applicant is also asked to provide an explanation to the review division along with any proposed language changes to labeling.

"This approach should improve the efficiency of communication by decreasing the number of back-and-forth negotiations between the division and the applicant," the draft states.

"In some cases, however, the applicant and review division might need to reach agreement based on the material submitted in the application, but subsequently (i.e., after approval) the applicant might need to submit a labeling supplement containing new data to support a labeling change," the draft states.

Creation of the guidance was called for under the June 2002 reauthorization of the user fee program. The good review management principles emphasize communication between FDA and the applicant as key to expediting and improving the review process.

Although FDA has had an internal draft since last fall, the guidance has been slow to develop. The agency originally planned to release the guidance on good review management principles at the end of 2002 (² Also see "PDUFA 2.5?: Delay In FY 2003 FDA Appropriations Has PDUFA III In Limbo" - Pink Sheet, 11 November, 2002., p. 14).

An updated goal called for release of the final document by the end of September, but Office of New Drugs Director John Jenkins, MD, has said that timeline would not be achieved (³ Also see "FDA Multi-Cycle Product Review Analysis To Begin In Fiscal 2004" - Pink Sheet, 30 June, 2003., p. 5). The draft now estimates the guidance will be finalized in October at the earliest.

In addition to streamlining labeling negotiations, the draft gives several other points of advice to FDA and industry to make reviews more efficient, many focusing on methods for better communication between the major players.

The document outlines steps the agency and applicant should take, beginning in presubmission and extending after an action letter.

"The agency believes that open communication of advice, guidance, and notification of deficiencies should occur at pivotal points during" the review process, the draft states.

The regulatory project manager should be used as the sole point of contact between the applicant and the review division to avoid repeated applicant inquiries.

"Based on the nature of communications between the applicant and the review division throughout the review process...it should be reasonably clear to the applicant whether the application may be headed toward approval or whether another review cycle will be needed," the draft states.

"It is generally not an efficient use of agency resources during this final critical period to be responding to frequent and redundant inquiries from the applicant."

Review project managers also are encouraged to continuously add new components to the action package throughout the review process. "In general, the action package should be completed and available to the signatory authority no later than two weeks before the PDUFA goal data for a priority application and no later than three weeks before the PDUFA goal date for a standard application," the draft guidance states.

FDA Defines Good Review Management; No Data In Labeling Negotiations

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