'Low-Hanging Fruit' Of Industry Comms Policy Addressed By Recent FDA Documents

Draft guidance documents issues by US FDA in January did not tackle the toughest off-label speech debates, but they did provide some useful information to guide company communications, experts said on a recent FDLI webinar.

Manufacturers are still waiting for US FDA to clarify its position on off-label communications, but recent draft guidance documents provide some helpful advice.

Three experts, including an FDA official, addressed important takeaways from the two documents that were issued in the closing days of the Obama administration to outline FDA policy on industry...

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