FDA: Voice of the Patient


About the FDA Patient Network

Created in 2012, the FDA Patient Network (PN) is part of the Office of Health and Constituent Affairs (OHCA). The Patient Network is a comprehensive program that works to expand and sustain communication with patients and their community.  The PN also helps educate patients, patient advocates, and their healthcare professionals about medical product regulations and we continue to look at ways to involve patients more effectively in regulatory decisions related to medical product safety and approval.
 
OHCA continues to provide resources that help patients and consumers find the information they need to support their own health care, whether they want to learn more about clinical trials and where to find studies or when accessing investigational products outside of trials might be appropriate.
 
Through this Network, we have created an entire section for patients on FDA.GOV that addresses concerns patients and caregivers have about medications and provide answers to questions about the lifecycle of medical product development.
 
The Patient Network is made up of:
 
  • patient specific pages on FDA.GOV that help you connect with the FDA through:
    • information about upcoming open public meetings.
    • opportunities to watch previously recorded webinars.
    • how to submit comments on FDA draft guidances.
  • Patient Network News - a twice monthly newsletter that shares information about:
    • new product approvals.
    • significant medication labeling changes.
    • new safety concerns on already approved medicines.
    • many other topics that are important to patients and patient advocates.
  • an annual meeting and periodic webinars that provide patients and their communities a way to learn more about the FDA process, previous topics have included:
    • What is an Advisory Committee
    • Under the Microscope: Periodic Product Development
    • Demystifying FDA: An Exploration in Drug Development
    • Pediatric Cancer Advocacy Outreach Meeting
    • Patient Dialogue on Unmet Needs in Diabetes

FDA Cardiovascular and Endocrine Liaison Program

The Cardiovascular and Endocrine Liaison Program (CELP) serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. CELP encourages and supports your active participation in forming FDA regulatory policies that promote healthy dietary and nutrition practices and advance the safety and effectiveness of human medical products that treat diabetes, hypertension, heart disease, and obesity.
Discover how you or your organization can collaborate with FDA! Please contact: Cardio.Endo@fda.hhs.gov
 

 

Contact FDA

FDA Patient Network Program
Office of Health and Constituent Affairs
 
301-796-8460

Learn About Drug and Device Approvals

 

The development of drugs and medical devices follows well-established paths to make sure that they are safe and effective when they reach the public. From concept to approval and beyond, FDA:
  • Reviews research data and information about drugs and devices before they become available to the public.
  • Watches for drug problems once drugs and devices are available to the public.
  • Monitors drug information and advertising.
  • Protects drug quality.
 

Drug and Device Development Processes

 
The development processes for drugs and devices are similar–each involves five basic steps. However, the processes differ within those steps. Click on either Drug Development or Device Development to learn more.
 

Comment on Current FDA Draft Guidances

 

As a Regulatory Agency, FDA publishes rules that establish or modify the way it regulates; 
  • foods
  • drugs
  • biologics
  • cosmetics
  • radiation-emitting electronic products
  • medical devices
  • tobacco products
 
FDA rules have great impact on the nation’s health, industries and economy. These rules are not created by chance or in a vacuum. They are formed with the public’s help.
 
By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule. The public can submit comments about the proposed regulation directly to the agency (through the mail or online at www.regulations.gov).
 
On regulations.gov you can find, read, and comment on FDA draft guidances and other FDA related documents. 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.
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance before the close date.
 
To view current opportunities to comment on guidance, please click here.

Patient Network Newsletter

 

FDA's Office of Health and Constituent Affairs provides this bi-weekly newsletter to patients, caregivers, patient advocates and other healthcare professionals and is intended to inform you of FDA-related information on a variety of topics including:
 
  • new product approvals,
  • significant labeling changes,
  • safety warnings,
  • notices of upcoming public meetings,
  • proposed regulatory guidances,
  • opportunities to comment, and
  • other information of interest
View the current newsletter and to sign up for the Patient Network Newsletter click here.
 
 

Expanded Access (Compassionate Use)

 
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices.
 
Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when patient enrollment in a clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials), patients may be able to receive the product, when appropriate, through expanded access.
 
To read more about expanded access, click here.

 

When a Patient Speaks

FDA’s Patient Representative Program brings the patient voice to discussions about new and already approved drugs, devices and policy questions. These representatives provide FDA with the unique perspective of patients and family members affected by a serious or life-threatening disease. In this short video, a variety of patient reps discuss different aspects of their roles and responsibilities.  To contact someone with the Patient Representative Program, please email: PatientRepProgram@fda.hhs.gov.