FDA Considers Incorporating Patient Input In Generic Drug Assessments

US Agency Mulls Changes But Acknowledges Challenges For Off-Patent Medicines

The popular patient-focused drug development model for new drugs might not fit for generics, in part because the affected patient groups would be much larger.

Sign outside of FDA's headquarters in White Oak, MD
Patient influence at the FDA could increase if patient input is allowed to influence generic drug decisions

US Food and Drug Administration officials want to incorporate patient input into generic drug decisions and regulations, but may not be able to use the traditional model to do so.

The challenge is that Office of Generic Drugs issues appeal to many more patients than those explored by the Office...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Regulation

More from Policy & Regulation