The US Food and Drug Administration’s drug industry two-step – providing development advice while also independently assessing applications – continues to run smoothly, but Commissioner Robert Califf does not want its dual role taken for granted.
Califf: Industry Should Be Reminded Of US FDA’s Separate Development Advice, Application Assessment Roles
Experts wonder why the FDA Commissioner commented on a system seemingly working fine, but Califf says it is necessary to remember the potential conflict between the two roles.
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