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Public Policy Newsletter Article

Great Discussion with the FDA Office of New Drugs

  • 2019-10-24T15:00:00.000+0000
  • California
  • Author: Emily Cassel

On October 18, Biocom members met with Keith Flanagan and Maarika Kimbrell from the FDA’s Office of New Drugs (OND) to discuss OND’s regulatory program modernization. Reorganization of OND was recently approved by Congress in an effort to adapt and evolve with the rapidly changing ecosystem. New changes include clinical review offices that align in related disease areas, more focused disease expertise in clinical review divisions, and support offices for policy, science, and operations. OND discussed its challenges, including growing stakeholder engagement and expectations, new science and technology, and the healthcare system’s cost restraints and growing workload, and welcomed feedback from our members.

Members shared challenges and insights, which included a need for consistency across the FDA, recognizing that one size does not fit all, though similar situations should be treated similarly. We are thankful for this opportunity to share opinions in an effort to help OND provide regulatory clarity to promote innovative and effective drug development across multiple therapeutics areas.

On November 7th, OND will host a public meeting and seeks additional comments on where policy clarity and scientific discussion is needed to promote effective drug development. Please reach out to Emily Cassel for more information.