Under The Poliscope: Bringing Science Policy Into Focus
May 2, 2017

One of the most frequent exasperated questions I face when I talk to NIH stakeholders is, “Why can’t federal agencies harmonize more? Don’t you people ever talk to each other?!?” I am happy to share tangible proof that the clear answer is “Yes!”  Today, NIH and FDA released the final version of a template document I blogged about last March that will assist NIH-funded investigators in preparing Phase 2 and 3 IND/IDE trial protocols. In utilizing this template, investigators can prepare documents that will help enable efficient and speedy reviews by both the IRB and the FDA.

Under The Poliscope: Bringing Science Policy Into Focus
Dr. Carrie D. Wolinetz

Carrie D. Wolinetz, Ph.D.
Associate Director for Science Policy, NIH

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