Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.

With the aim of lowering prices and improving access to certain prescription drugs, the US FDA and HHS have decided to allow imports from Canada. To enable this, the FDA has finalized the rule allowing importation and issued accompanying guidance.

New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.