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When Expanded Access Also Means Off-Label Use, US FDA May Need New Policy

 
• By Derrick Gingery

For now, FDA is using a case-by-case approach for reviewing and approving expanded access applications asking for off-label uses.

FDA entrance sign 2016
FDA has encountered situations where an expanded access IND is necessary to allow an off-label use of an approved drug.

The US Food and Drug Administration's expanded access program now is receiving requests for off-label uses of approved drugs, creating a new policy question as the single-patient IND program likely is on the cusp of more growth.

Approved drugs do not require special FDA permission for an off-label use. In many cases, especially in oncology, off-label use is common and widely accepted, even by payers. But patients...

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