FDA's Compassionate Use Initiatives: Web Clearinghouse, Guidance Documents
This article was originally published in The Pink Sheet Daily
Expanded Access Navigator offering directory of manufacturers' procedures and points of contact will depend upon industry cooperation, stakeholders at Reagan-Udall Foundation meeting conclude.
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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.
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.
Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.