The US Food and Drug Administration’s questions prepared for outside advisors often raise concerns from committee members who want greater clarity or sharper definitions before voting on a difficult regulatory topic.
US FDA’s ODAC Pushes Back Against ‘Leading’ Questions
The questions posed by the FDA to its Oncologic Drugs Advisory Committee for its most recent meeting all but answer themselves. The committee ultimately supported the agency’s negative view of the applications under review, but pushback during the meeting may encourage the agency to strike a more neutral tone in the future.
