Regulatory flexibility has become a notable focus for the US Food and Drug Administration in recent years as politicians and the US public increasingly call for the agency to accept higher levels of risk and uncertainty when confronted with serious and life-threatening diseases with limited or no treatment options.
Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility
Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.
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