WASHINGTON – On Thursday, the Trump administration held a closed-door press conference to allow senior Food and Drug Administration officials to anonymously criticize an experimental Huntington’s disease treatment developed by UniQure.
In the past, when faced with controversial regulatory issues, the agency often held public meetings of independent advisory committees (known in industry parlance as advisory committee meetings or adcoms). Patients, physicians, and other interested parties were given the opportunity to comment. They were given a transparent look inside the scientific dialogue between company leaders and regulators who publish their own analysis of medical product approval applications.
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UniQure announced last fall that clinical trials showed its treatment dramatically slowed the progression of Huntington’s disease. The company seemed confident in filing for approval. The FDA responded that it was not satisfied.
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