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A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new drugs.
The language was added Wednesday to a federal spending bill report that covers the FDA. It would bar the agency “from accepting, reviewing, or considering any covered clinical data generated by a clinical investigation site” in China, Russia, Iran or North Korea when a company submits an application. Known as INDs, the applications are the official process by which biopharma companies begin human trials that can eventually lead to an approval submission.