Jumpstarting U.S. Device Trials? FDA Makes Effort In New Draft Guidelines

Article preview from "The Gray Sheet"- November 14, 2011

New FDA guidances aim to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.

Jumpstarting U.S. Device Trials? FDA Makes Effort In New Draft Guidelines

Article preview from "The Gray Sheet"- November 14, 2011

FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the U.S.

The first draft guidance, issued Nov. 10, focuses on streamlining requirements to initiate and make changes to very-early-stage clinical studies, including first-in-human trials, which are now often conducted overseas for breakthrough technologies.

As part of that effort, FDA is also launching a pilot program where selected sponsors will seek to initiate early feasibility trials, including first-in-human studies, by applying the draft guidance recommendations.

The seconddraft guidance focuses more generally on the investigational device exemption process, with the goal to offer flexibility in addressing outstanding issues to allow clinical investigations to begin without unnecessary delays. Comments on both draft guidances are due Feb. 8, 2012.

Industry representatives and physicians have complained that too many barriers stand in the way of initiating studies in the U.S., and that FDA’s IDE review process is too burdensome.

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