When Expanded Access Also Means Off-Label Use, US FDA May Need New Policy
For now, FDA is using a case-by-case approach for reviewing and approving expanded access applications asking for off-label uses.
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Agency’s clinical experts favor granting access under regulations intended for investigational drugs but ‘lawyers want consistency under the law,’ FDA’s Woodcock says; use of the expanded access pathway for approved agents is generally unnecessary but may provide sponsors with some regulatory cover, external experts say.
New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.
Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders
In interview with the Pink Sheet, former US FDA commissioner Scott Gottlieb said that opposition to the modified House version of the right-to-try legislation ultimately led to the less favorable Senate bill becoming law.