'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Draft guidance documents issues by US FDA in January did not tackle the toughest off-label speech debates, but they did provide some useful information to guide company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.
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Two draft guidance documents would allow a broader range of communications with payers and others about information not included on device labeling, or concerning products without FDA approval.
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.