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FDA Considers Incorporating Patient Input In Generic Drug Assessments

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

 
• By Derrick Gingery

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 of New Drugs’ patient-focused drug development (PFDD) program. William Chong,...

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