FDA, Industry Still Grappling With 'Consistent-With-Labeling' Guidance
In June, US FDA gave manufacturers permission to discuss their devices in ways that strayed outside the official labeling language as long as they met certain standards. FDAers and lawyers discussed the practical implications of that rule at a recent conference in Washington DC.
You may also be interested in...
Two newly finalized guidance documents from US FDA help broaden the scope of acceptable manufacturer communications. One addresses communications with payers, while the other discusses communications that are consistent with approved labeling.
US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.
The US Food and Drug Administration and the Veterans Health Administration are partnering to create tools that can help novel technology reach patients more quickly and easily.