NIH & FDA Request Comments on Draft Protocol Template for Phase 2 or 3 Clinical Trials

The NIH and FDA have released a Notice requesting comments on a draft protocol template that could be used by investigators proposing phase 2 or 3 clinical trials that require Investigational New Drug or Investigational Device Exemption applications. The desired outcome of the proposed template is more consistently organized protocols that contain all necessary information for review by the agencies.

Comments must be submitted HERE by April 17, 2016.

Questions about the template or submitting a response should be directed to SciencePolicy@od.nih.gov.

 

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