For Patients

Learn About FDA Patient Engagement

Engage with FDA! Our mission is to improve public health. We can’t do it without you: the patients, caregivers, and advocates. We want to hear directly from you and learn about your experiences, preferences and needs as they relate to FDA-regulated medical products.

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Patients Ask FDA

Ask a question or request a meeting with FDA.

Report a Drug or Medical Device Issue to FDA

Report a safety concern or negative event with an FDA-regulated medical product using FDA’s information and event reporting program, MedWatch.

Submit Comments to FDA on Pending Regulatory Policies

Share your knowledge and expertise with FDA to make your voice heard regarding pending regulatory policies.

Contact the Patient Affairs Staff

Connect with FDA’s Patient Affairs Staff directly. We help patients become more informed and involved in FDA regulatory decisions related to medical products.

About the FDA Drug and Device Approval Process

Learn about the drug and medical device approval process. This process follows well-established paths to make sure that medical products are safe and effective when they reach the public.

FDA Drug Approvals

Get information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products.

FDA Device Approvals

Find information about what the device is, how it works, when it can be used, and when it should not be used.

FDA Recalls, Market Withdrawls, & Safety Alerts

Review information gathered from press releases and other public notices about recalls, withdrawls, and safety alerts of FDA-regulated products.

Expanded Access: Information for Patients

Learn about expanded access, including information about the expanded access process, what FDA considers, and what costs may be involved.

Learn about Expanded Access and other Treatment Options

Learn about treatment options for when a patient does not respond to current approved treatments.

Clinical Trials: What Patients Need to Know

Learn more about clinical trials and find a trial that might be right for you.

Patients Matter Video Series

Watch short videos developed to inform patients and other stakeholders about FDA patient initiatives and patient engagement efforts.

When a Patient Speaks: Testimonials from FDA Patient Representatives

Watch short videos where FDA Patient Representatives share what it means to serve in their unique role.

Patient Listening Sessions

Patients, caregivers, advocates and community representatives can share their experiences, perspectives, and needs related to their health or a disease by talking directly with FDA staff.

About the Patient Affairs Staff

Learn more about FDA’s Patient Affairs Staff. We help patients become more informed and involved in FDA regulatory decisions related to medical products.

About FDA Advisory Committees

Learn more about why and how FDA advisory committees weigh the available scientific evidence and provide scientific advice on the safety, effectiveness, and appropriate use of FDA regulated products.