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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.
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.
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.
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.
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FDA Public Meetings
Contact the FDA Patient Affairs Staff
(301) 796-8460
Hours Available
Patient Affairs Staff
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