FDA News: Issue 3-1 May 2024

Author: [AUTHOR] Published on 5/10/2024 5:00:00 AM

FDA Office of Clinical Pharmacology Seeks Public Input on Opportunities and Priorities

On April 26, 2024, the US Food and Drug Administration (FDA) announced the availability of a Federal Register notice entitled Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology. This Federal Register notice establishes a public docket to solicit input from interested parties on specific and actionable policy topics that could be prioritized, developed, and implemented by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of Clinical Pharmacology (OCP) to support effective drug development programs.

The Agency is particularly interested in seeking input on: (1) topics for development of new clinical pharmacology/translational medicine guidances to improve clarity and promote effective drug development; (2) topics and concepts where further clarity on OCP's existing guidances may be warranted; and (3) topics that promote patient centricity in drug development and regulatory assessment.

The “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology” Federal Register notice is available at: https://www.federalregister.gov/documents/2024/04/26/2024-08956/promoting-effective-drug-development-identifying-opportunities-and-priorities-for-the-food-and-drug. Please refer to the notice for more details. You may submit your comments to the docket (Docket No. FDA-2024-N-1592) available at https://www.regulations.gov up to 60 days following publication in the Federal Register.

Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.



Subscribe Now

Sort by:
Photo Gallery
Recent News
Contact Us