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US FDA issues draft guidance on formal dispute resolution request
Pharma News

Nandita Vijay, Bengaluru
Saturday, September 19, 2015, 08:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has issued a draft guidance on formal dispute resolution request (FDRR) which enables appropriate review of the scientific controversies between the regulator and the industry, including possible evaluation by a scientific advisory committee. The regulator has issued a 60-day timeline to seek industry comments. Pharma experts now view this guidance as a useful move.

This guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to resolve scientific or medical disputes that cannot be resolved at the division level.

The formal dispute resolution (FDR) procedures provide a structured format to resolve disputes.

According to Kaushik Desai, honorary general secretary, Indian Pharmaceutical Association and pharma consultant, this guidance is a further update to the two-year-old draft. Now this is a good move by the regulator which has now set a 30-day deadline for FDR. Therefore industry should read the guidance and comment before December, 2015.

During the review of an investigational new drug application (IND), new drug application (NDA), biologics license application (BLA), or abbreviated new drug application (ANDA), a wide variety of important issues are discussed that are central to product development. Sometimes, a sponsor may disagree with the Agency on a matter, and a dispute arises. Since these disputes often involve complex scientific or medical matters, it is critical to have procedures in place to help ensure open, prompt discussion, noted the regulator.

This guidance revises the draft guidance for industry and review staff issued in March 2013. It revision expands the scope to include FDRRs for human drug applications covered under the Biosimilar User Fee Act of 2012 (BsUFA).

Additionally, certain areas were revised to provide more clarity, such as when a matter is and not appropriate for an FDRR. The norms also clarify that CDER and CBER intend to manage formal requests for appeals related to an application for a user fee product under any of the available regulatory mechanisms covering 21 CFR 10.75, 312.48(c), 314.103(c)), through the FDR process.

The FDR User Fee Performance Goals contain specific time frames to resolve disputes affecting an IND, NDA, or BLA. For disputes involving human drug applications covered by Prescription Drug User Fee Act (PDUFA), the objective is to respond to an appeal of a dispute within 30 days of the receipt of the written appeal. In the Generic Drug User Fee Amendments of 2012 (GDUFA), the FDA agreed to specific performance goals for the review of applications.

For those applications not covered by PDUFA, Biosimilar User Fee Act (BsUFA) of 2012 or GDUFA, and applications for CBER regulated medical devices, the procedures indicated in this guidance will be applied and the time frames will be met as resources permit.

The regulatory actions that would be appropriate for an FDR are a complete response (CR) letter, IND clinical hold, request for breakthrough therapy designation and for proprietary name review denied, besides refuse to receive for an ANDA.

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