The proposed review model for new molecular entity new drug applications and original biologics license applications remains under discussion along with several other Prescription Drug User Fee Act reauthorization issues.

Industry and FDA have agreed the pilot program would not be optional, according to minutes of a Jan. 10 negotiation. Issues such as allowing submissions during the 60-day filing period and in response to application issues revealed during mid- and late-cycle meetings remain unresolved.

Both sides also have not reached a final agreement on allowing clarifying questions for companies that do not have an approved application with FDA.

Representatives had been asking for enhanced and streamlined agency communication with inexperienced sponsors, including the ability to ask simple and clarifying questions of reviewers (Also see "FDA Could Answer "Clarifying" Questions, But Only For Firms Without Approved Product" - Pink Sheet, 28 February, 2011.).

The agency said in the minutes the company asking for the answers should have to prove its eligibility, rather than the agency.

Industry wants the companies to be able to discuss the pending issues with the agency via teleconference before submitting a formal request for answers. FDA said in the minutes it is willing to consider it, but “not as a formal commitment for each request for clarification.”

Agency resource issues related to the proposal also are not decided.

While these issues and others remain, the PDUFA negotiations are drawing to a close elsewhere, with final agreements on several topics (see related story, Also see "PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue" - Pink Sheet, 7 March, 2011.).

Type C Meeting Policy, Other Issues Not Resolved

Even though industry and FDA have agreed on uses for Type C meetings, the Steering Group did not approve the proposal at the Jan. 10 meeting. The group will address it at a future meeting, according to the minutes.

Type C meetings, the lowest-priority sponsor-FDA communication, could be either written or face-to-face, but the agency would decide which form would be used (Also see "FDA May Require NDA Pre-Filing Meeting Under PDUFA V Review Model; Pilot Launching Soon" - Pink Sheet, 28 February, 2011.).

Issues regarding data standards for application submissions and real-time oversight of clinical trials also remain unresolved, as do potential changes to the PDUFA inflation adjuster formula.

The group decided the Clinical Data Interchange Standards Consortium would be used to develop submission standards for clinical data. A public process will be needed to pick a developer for non-clinical data submissions, according to the minutes.

The inflation adjuster and PDUFA complexity factor could be changed as both sides consider the effects of federal wage freezes and the slow economic recovery (Also see "User Fee Inflation Calculations May Need To Change Due To Slow Economic Recovery" - Pink Sheet, 17 January, 2011.).

Talks also continue about proposals related to non-inferiority trial designs, patient-reported outcomes and biomarkers, according to the minutes.

By Derrick Gingery

NDA Review Pilot Will Be Mandatory, Assuming Program Flies At All

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