CDER Director Requests Accelerated Approval Reforms and Expresses Worries over Recent Court Decisions

April 28, 2022

Patrizia Cavazzoni aired her concerns about recent court cases and made requests regarding accelerated approval reform in a recent hearing before the US Senate Health, Education, Labor, and Pensions Committee. Cavazzoni, Director of the enter for Drug Evaluation and Research (CDER) at the FDA, worries that the court case would stymie rare disease research, particularly impacting children.

According to Zachary Brennan of Endpoints News, “The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.”

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(Source: Endpoints News, April 26th, 2022)

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