Formal Dispute Resolution: FDA Finalizes Guidance
The US Food and Drug Administration (FDA) on Friday finalized its guidance on the system for formally disputing scientific or medical issues between a sponsor and the agency.
While the guidance remains largely similar to the agency's revised draft version issued in September 2015, FDA says it has provided clarifications on several issues and updated the guidance to reflect changes to its dispute resolution goals for generic drugs under the reauthorized Generic Drug User Fee Amendments (GDUFA II).
Under the first iteration of GDUFA, FDA only committed to "aspire to respond" to a dispute related to a generic drug submission within 30 days of receiving a written appeal, whereas GDUFA II sets specific goals for the percentage of disputes above the division level the agency will respond to within 30 days.
According to FDA, the final guidance also clarifies that the formal dispute resolution process described within applies only to disputes between sponsors and the agency, and does not apply to other individuals or entities that wish to dispute an issue with the agency.
Additionally, the final guidance explains that agency communications such as meeting minutes or general advice letters are not appropriate for formal dispute resolution as sponsors are not bound to follow those communications and have other avenues outside formal dispute resolution to discuss such advice, such as Type C guidance meetings for new drugs or Type 2 meetings for biosimilars.