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Expanded Access Postings Not Promotional, Unless Done In ‘Promotional Context,’ US FDA Says

 
• By Derrick Gingery

Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.

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Some sponsors still question whether posting an expanded access policy constitutes off-label promotion. • Source: Shutterstock

Sponsors now have it in writing that including expanded access policies on their websites would not be considered off-label promotion by the US Food and Drug Administration.

The agency wrote in updated draft question-and-answer guidance on expanded access to investigational drugs that if a sponsor mentions...

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