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US FDA’s ODAC Pushes Back Against ‘Leading’ Questions

 
• By Michael McCaughan

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.

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Did the FDA push ODAC too much with its voting question on Pepaxto? • Source: Shutterstock

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.

And then there are the questions prepared by the FDA for its Oncologic Drugs Advisory Committee meeting on 22 September:

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