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In this section: For Patients

For Patients

Learn about other treatments, drug/device approvals, public meetings and more.

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Learn About FDA Patient Engagement

Learn about the FDA Patient Representative Program and the Patient Engagement Collaborative to see how patients and caregivers are working with the FDA to have their voice included in medical product approvals and FDA policy.

Learn About Drug and Device Approvals

FDA is speeding up the approval process for Drugs and Medical Devices. Learn how medical products are approved.

Learn About Expanded Access and Other Treatment Options

Expanded access, investigational new drugs and off-label use of approved products.

Learn About the Patient Affairs Staff

The FDA Patient Affairs Staff works to improve, expand and sustain communication with patients and their community.

Guide to Submitting Comments to the FDA

Read FDA Federal Register Notices and submit your comments on current FDA draft guidances and other policy related questions that affect patients and caregivers.

Clinical Trials: What Patients Need to Know

Clinical trials, informed consent and FDA's role in ensuring that people of different demographics are included in clinical trials (FDASIA section 907).

Get Illness/Condition Information

FDA brings the patient perspective into the review of medical products that treat Cancer, Hepatitis B & C and HIV.

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Request to Connect

FDA invites patients and their caregivers to use the Request to Connect portal to ask questions to FDA or to request a meeting.

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Patients Matter Video Series

Watch a series of short videos developed by FDA’s Patient Affairs Staff to teach patients and other stakeholders about FDA and patient engagement efforts.

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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.

Drug Approvals

Device Approvals, Denials and Clearances

Contact the Patient Affairs Staff

FDA Advisory Committees

Webinars and View Presentations Given by FDA Experts

Rare Diseases Web Resources

FDA Advisory Committee Calendar

FDA Meetings, Conferences and Workshops

CBER (Biologics) Workshops, Meetings & Conferences

CDER (Drugs) Workshops, Meetings & Conferences

CFSAN (Food Safety) Workshops, Meetings & Webinar

Contact the FDA Patient Affairs Staff

(301) 796-8460

Hours Available

Follow Us on Twitter @FDAPatientinfo

Tweets covering a range of FDA-specific topics and numerous activities that are of interest to patients.

Request to Connect Webform

Submit a question or meeting request through the Request to Connect webform