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

14 Nov 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.

FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the U.S.

The first draft guidance, issued Nov. 10, focuses on streamlining requirements to initiate and make changes to very-early-stage...