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.

FDAEntrance_1200x675

Stakeholders were concerned when FDA slipped changes to its “intended use” regulations into a 2015 proposed rule on tobacco-derived drug products. While the agency has modified the regulatory language, it continues to require manufacturers to specify in labeling how a product is intended to be used.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

More from Agency Leadership