Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

Regulatory NewsRegulatory News | 07 October 2014 |  By 

The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards.

Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-private initiative partly supported by FDA and working on similar development acceleration initiatives. This is incorrect, and we regret the error.

As explained in its new guidance document, Critical Path Innovation Meetings, FDA sets up meetings under the CPI to allow the public and industry to help FDA's Center for Drug Evaluation and Research (CDER) to recognize potential bottlenecks representing a barrier to drug development in a critical area.

"The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development," the guidance explains. "CDER will identify some of the larger gaps in existing knowledge that requesters might consider addressing in the course of their work. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters."

FDA said potential topics of discussion can include biomarkers under its Biomarker Qualification Program (BQP), clinical outcomes assessment (COA) tools, natural history study designs, emerging technologies and even "innovative conceptual approaches to clinical trial design and analysis."

Discussions will lead to FDA offering its perspective on a given tool or topic and, if appropriate, advice that a company work jointly with other stakeholders (new or existing) to advance development of a tool. "CDER expects that the CPIM will also provide FDA with exposure to methods and techniques that may have value in drug development," it said.

FDA's guidance also contains various information about actually requesting a meeting, such as the preparation of CPIM meeting packages, how to explain the purpose of the requested meeting, and the desired outcome of the meeting.


Critical Path Innovation Meetings

Federal Register


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