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US FDA’s New Generics Chief: We Need More Flexibility For Complex Products

 
• By Derrick Gingery

Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

generic drugs
Iilun Murphy became the permanent Office of Generic Drugs director in June. • Source: Shutterstock

The new head of the US Food and Drug Administration’s generic drugs office suggested their regulatory foundation, the Hatch-Waxman Act, may need some updates to handle the growing number of complex products seeking approval.

Iilun Murphy, who became director of the Office of Generic Drugs on 18 June, said in an interview with the Pink Sheet that the Hatch-Waxman Act was enacted in 1984 envisioning largely immediate-release oral generic medications

Key Takeaways

  • New OGD Director Iilun Murphy began her career as a pediatrician and continues to teach pediatrics.

  • Jacqueline Corrigan-Curay’s supervision of the generics program includes briefings on challenging issues

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