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  1. CDER Offices and Divisions

Office of Drug Evaluation Sciences

Vision

As regulatory scientists, ODES promotes innovative approaches to drug evaluation through the promotion of novel drug development tools, standardized drug evaluation approaches, and regulatory science research, focusing on: Clinical Outcome Assessment (COA), Biomedical Informatics and Regulatory Review Science (BIRRS), research, biomarkers, and innovative technologies

Purpose

The Office of Drug Evaluation Sciences (ODES) promotes innovation in drug evaluation science to facilitate the availability of new drugs that are safe and effective for their intended use. ODES will collaborate with stakeholders to:

  • Provide expertise and assessments of tools (e. g., clinical outcome assessments, biomarkers, surrogates) for OND clinical offices to facilitate IND program-specific drug development and review, and for qualification of these tools for broader application.
  • Develop process, policy and guidance on drug evaluation science topics, specifically those related to tool development (e.g., COAs, biomarkers, surrogate endpoints, digital health technology)
  • Facilitate intramural and extramural research that supports the regulatory mission of OND
  • Provide standardized and innovative approaches to safety analyses for NDA/BLA application review
  • Provide support for bioinformatics related to data standards and safety analytics.
  • Provide a report to Congress on certain information regarding clinical trial participation by demographic subgroups and subset analysis of the resulting data and to address the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups is included in applications submitted to FDA.

As regulatory scientists, ODES promotes innovative approaches to drug evaluation through the evaluation and support for development of novel drug development tools, standardized drug evaluation approaches, and regulatory science research, focusing on:

Clinical Outcome Assessment (COA)

Integrating the patient voice into drug development through COA endpoints that are meaningful to patients, valid, reliable and responsive to treatment.

Biomedical Informatics and Regulatory Review Science (BIRRS)

Achieving excellence in evidence-based regulatory decisions through integration of medicine and analytical informatics.

Office of New Drugs Regulatory Science Research

Providing education, support, infrastructure, and oversight to foster regulatory science research in OND.

Biomarker Qualification Program

The Biomarker Qualification Program provides a framework for the development, qualification, and regulatory acceptance of biomarkers and through this Program, biomarker developers may request regulatory qualification of a biomarker for a particular context of use in drug development.

Digital Health Technologies (DHT)

DHT encompass systems that use software, connectivity, computer platforms and systems for healthcare and related purposes. Applications include general wellness apps, medical device apps and systems generating data that may be used in drug trials, including decentralized clinical trials.  ODES supports CDER and FDA in fostering consistency regarding the use of DHTs in drug development and assuring that the Center’s and Agency’s DHT-related activities are reflective of the perspective and input of OND.

Drug Trials Snapshot

The ODES immediate office also has staff dedicated to developing the Drug Trials Snapshot (DTS), FDA’s action plan in response to Section 907 of Food and Drug Administration Safety and Innovation Act (FDASIA)  to report to Congress on certain information regarding clinical trial participation by demographic subgroups and subset analysis of the resulting data and to address the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups is included in applications submitted to FDA.

Contact Us

Mailing Address
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs, Immediate Office - Mail Stop 6311
10903 New Hampshire Avenue
Silver Spring, MD 20993

Telephone: 301-796-0700
Fax: 301-796-9856
E-mail: ONDCommunications@fda.hhs.gov

 



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