Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Development & Approval Process | Drugs

Development & Approval Process | Drugs

                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources Home
          Drugs
          Development & Approval Process | Drugs
          CDER Patient-Focused Drug DevelopmentDevelopment & Approval Process | Drugs CDER Patient-Focused Drug Development
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintPatient-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

Sign post
PFDD Methodological Guidance Series

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 Patient-Focused Drug Development Meetings

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


Stack of Folders and Pen
Condition-Specific Meeting Reports

This webpage hosts an alphabetical listing of condition-specific meeting reports and other information related to patients’ experience. These meetings include FDA-led Patient-Focused Drug Development (PFDD) meetings, Externally led PFDD meetings, and Patient Listening Sessions.

Helpful Links

News and Events

Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement

Upcoming COA Grant Program Public Meetings

Upcoming FDA-led PFDD Meetings

Voice of the Patient Reports

Guidance

PFDD Methodological Guidance Series

Draft Guidance on Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs

21st Century Cures and PDUFA VI

21st Century Cures Act

eCTD Technical Conformance Guide
	Assessment of the Use of Patient Experience Data in Regulatory Decision-MakingPDUFA VI

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
	​Clinical Outcome Assessment Compendium​
	CTTI/FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials


EL-PFDD Meeting Program Resources

Guidelines for Developing a Letter of Intent (LOI)

Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience

Cover Page Guidelines
	Frequently Asked Questions

Other Patient-Focused Efforts at FDA

Patient Affairs Staff

Initiatives for Patients to Engage with FDA
	Patient Listening SessionsCDER Professional Affairs and Stakeholder Engagement

Oncology Center of Excellence

CBER Patient Engagement

CDRH Patient Engagement

CDRH Patient Preference Initiative

                                                                                  Content current as of:
      11/01/2023Development & Approval Process | Drugs

          
                        Clinical Data Summary Pilot Program
          Drug Development Tools | DDTs
          Guidance Documents for Drug Applications
          Laws, Regulations, Policies and Procedures for Drug Applications
          Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME)


                        Drug Development Tool (DDT) Qualification Programs
          CDER Small Business & Industry Assistance (SBIA)
          Conducting Clinical Trials
          Development Resources
          Drug Approvals and Databases
          Forms & Submission Requirements
          How Drugs are Developed and Approved
          New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
          Pharmaceutical Quality Resources
 CDER Patient-Focused Drug Development
                          Get regular FDA email updates delivered on this topic to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop