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  1. Development & Approval Process | Drugs

CDER Patient-Focused Drug Development

Patient-Focused Drug Development

What is Patient-Focused Drug Development?

Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.

The primary goal of patient-focused drug development is to better incorporate the patient’s voice in drug development and evaluation, including but not limited to:

  • Facilitating and advancing use of systematic approaches to collecting and utilizing robust and meaningful patient and caregiver input to more consistently inform drug development and regulatory decision-making
  • Encouraging identification and use of approaches and best practices to facilitate patient enrollment and minimizing the burden of patient participation in clinical trials
  • Enhancing understanding and appropriate use of methods to capture information on patient preferences and the potential acceptability of tradeoffs between treatment benefit and risk outcomes
  • Identifying the information that is most important to patients related to treatment benefits, risks, and burden, and how to best communicate the information to support their decision making.

What We Do

The Patient-Focused Drug Development Program Staff leads initiatives and provides strategic, regulatory, program, and policy assistance within the Center for Drug Evaluation and Research (CDER) to facilitate the incorporation of patient input into decision-making.

Connect with FDA’s CDER Patient-Focused Drug Development Program Staff

Email: PatientFocused@fda.hhs.gov

To get updates about CDER's Patient-Focused Drug Development programs, subscribe to our free email subscription service by clicking on the button near the top of the page.


On This Page

On this page, you will be able to link to more information on FDA’s PFDD efforts as well as other external resources.

Program Areas

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21st Century Cures and PDUFA VI

FDA is developing a series of methodological guidance on the collection of patient experience data, and the use of such data and related information in drug development.

Doctor giving presentation

COA Grant Program

FDA developed a COA Pilot Grant Program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific disease indications.

Woman asking question at meeting

FDA-led PFDD Meetings

FDA’s PFDD meetings have provided key stakeholders, including FDA, patient advocates, researchers, drug developers, healthcare providers, and others, an opportunity to hear the patient’s voice.

Speaker at podium

Externally-led PFDD Meetings

FDA welcomes patient organizations to identify and organize patient-focused collaborations to generate public input on other disease areas.

Helpful Links

CDER Patient-Focused Drug Development

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