Industry Groups Petition To Block FDA Intended-Use Rule
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 The agency has yet to respond to a petition asking for the rule to be withdrawn.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...
‘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.
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.
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.