Rules and Regulations. Notice; establishment of a public docket; request for comments

Agency: Food and Drug Administration, HHS
Action: Notice; establishment of a public docket; request for comments
Citation: FR Doc. 2024-08956 · Docket No. FDA-2024-N-1592

Summary

The Food and Drug Administration (FDA or Agency) is establishing a public docket entitled “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology.” The purpose of this docket is 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.

Dates

Although you can comment at any time, to ensure that the Agency considers your comment, submit either electronic or written comments by June 25, 2024.

Supplementary Information

I. Background Clinical pharmacology impacts many important aspects of drug development including, but not limited to, dose selection and optimization, clinical trial inclusion and exclusion criteria, and evidence generation for safety and effectiveness determinations. Clinical pharmacology derived recommendations are also critical for optimizing pharmacotherapy in clinical practice ( e.g., by informing patient-specific treatment strategies). Within CDER, OCP leverages clinical pharmacology information on drug disposition, disease biology, pharmacology, and determinants of response variability to support risk/benefit determinations and therapeutic individualization recommendations for patients and practitioners. OCP's mission is to advance the development of innovative new medicines by applying state-of-the-art scientific principles and promoting therapeutic optimization and individualization. OCP fulfills this mission through its core functions of regulatory review, regulatory research, and development and implementation of scientific guidances and policies. To facilitate effective and efficient drug development, FDA is engaged in multiple, high-priority policy initiatives. Consistent with FDA's broader initiatives and modernization efforts, OCP works collaboratively with stakeholders to develop and implement contemporary guidance and policy in the multidisciplinary field of clinical pharmacology to share the current regulatory thinking on a topic and promote effective drug development programs. FDA is establishing a public docket to solicit input from interested parties on specific and actionable clinical pharmacology-relevant policy topics that could be prioritized, developed, and implemented by OCP staff. II. Request for Comments FDA is soliciting specific, actionable policy suggestions that could be prioritized, developed, and implemented in the near-term by OCP staff to promote effective drug development programs. We emphasize that the focus of this request is to seek input in the multidisciplinary field of clinical pharmacology. The Agency welcomes any relevant information that interested parties wish to share in a submission to the docket. We are 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. Please provide a rationale to support your suggestion and highlight relevant aspects that could be considered in guidance development. 2. Topics and concepts where further clarity on OCP's existing guidances may be warranted. Please provide a rationale to support your suggestions and actionable recommendations. 3. Topics that promote patient centricity in drug development and regulatory assessment. For FDA, patient-centric drug development and providing patient-centered clinical recommendations are important priorities. III. Electronic Access Persons with access to the internet may obtain relevant clinical pharmacology guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Dated: April 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-08956 Filed 4-25-24; 8:45 am]