USA – Experts Pitch FDA on Policies to Improve Drug Development

The US Food and Drug Administration (FDA) on Thursday heard from more than two dozen stakeholders on opportunities for the agency to promote more effective drug development programs at a public workshop at its headquarters in Silver Spring, Maryland.

“Effective drug development programs leverage the best available scientific knowledge to characterize the benefits and risks of a potential product and generate the data necessary to support product approval,” FDA says, noting its recent efforts to advance the use of real-world evidence and patient preference information.

However, FDA says it is looking for recommendations on new policies that it could implement in the near-term that would have an impact on drug development across multiple therapeutic areas.

Policy Suggestions

During the meeting, speakers representing drugmakers, patient groups, research institutions and consulting firms suggested policies and approaches FDA could pursue to promote more effective drug development.

Jennifer Hamilton, head of precision medicine at Regeneron Pharmaceuticals, suggested that FDA and industry could make drug development “smarter” by collaborating on regulatory standards and guidance for using genomic data to support submissions and labeling changes…