Top US FDA Officials Continue To Lament Advisory Cmte. Recruitment Difficulties
Strict conflict of interest rules have hampered the agency's ability to fill advisory committee vacancies.
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The agency historically has had challenges recruiting experts for its advisory committees. With most everyone working from home during COVID-19, that task was just made easier, 3D Communications’ Jim DiBiasi says.
FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.