Industry Groups Petition To Block FDA Intended-Use Rule
Executive Summary
Trade groups say FDA’s redefinition of intended use is an overreach and would pose constitutional problems. The agency has yet to respond to a petition asking for the rule to be withdrawn.
You may also be interested in...
US FDA Clarifies ‘Intended Use’ Policy For Approved Products
‘Totality of evidence’ establishes that a manufacturer intends a drug to be used for unapproved conditions, agency says; PhRMA says final rule disregards multiple courts’ protection of free speech.
Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing
Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.