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  1. Drug Safety and Availability

CDER soliciting comments regarding clinical trial innovation

[10/17/2023] Today, CDER announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.

CDER fosters drug development by providing scientific and regulatory advice and direction. This role is dynamically evolving in response to shifts in the drug development landscape, necessitating inventive clinical trial designs, innovative approaches to trial execution, an ever-expanding array of drug development tools, and the broader utilization of real-world data to inform decision-making.

In recent years, CDER has worked to advance clinical trial innovation through numerous efforts including public workshops, guidances, working groups and more. However, the incorporation of innovative clinical trial approaches in drug development programs presents some challenges that need to be further explored, along with opportunities.

CDER is conducting internal workshops and listening sessions and is working in partnership with Duke Margolis Center for Health Policy to host a public workshop on this topic on March 19 and 20, 2024. Responses to this public docket will inform the public workshop and CDER’s future work related to clinical trial innovation. CDER will share more details about the public workshop when available.

Comments to docket FDA-2023-N-4489 will be accepted until April 19, 2024. For more information about submitting public comments, please refer to Regulations.gov.

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