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Advisory Committees: US FDA Standardizing Decisions On When To Vet Applications

 
• By Sue Sutter

Center for Drug Evaluation and Research also is trying to ensure that questions posed at advisory committee meetings are written in clear and consistent language.

Palm trees
Office of New Drugs' Peter Stein wants to shake some trees to find clinicians who manage rare disease patients. • Source: Shutterstock

The US Food and Drug Administration’s drugs center is working to standardize how it decides to bring an application to an advisory committee, as well as the background materials and questions for those meetings.

Speaking at the Biopharma Congress on 26 February, Office of New Drugs Director Peter Stein discussed various measures the Center for Drug Evaluation and Research is taking to improve the...

Key Takeaways

  • CDER has developed a decision aid to standardize the process for deciding when to take an application to an advisory committee.

  • The drugs center...

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