FDA's Compassionate Use Initiatives: Web Clearinghouse, Guidance Documents

Expanded Access Navigator offering directory of manufacturers' procedures and points of contact will depend upon industry cooperation, stakeholders at Reagan-Udall Foundation meeting conclude.

A Reagan-Udall Foundation proposal for an Expanded Access Navigator could make it easier for physicians and patients seeking access to unapproved drugs by providing a central repository of information about biopharma manufacturers' policies and points of contact.

However, the proposal requires strong support from manufacturers for it to work and many questions remain to be answered, such...

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