As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs.

There are multiple ways to report a problem or contact FDA about human drugs. To get started, choose what you want to do:

Report an adverse event or side effect

Consumers and healthcare professionals are encouraged to report adverse events or side effects related to the use of prescription and over-the-counter drugs to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Report an issue with another FDA-regulated product like vaccines, food, tobacco or cosmetics

FDA’s SmartHub is designed to help you navigate to the appropriate form or resources to report a problem with an FDA regulated human or animal product.

Report a drug shortage

Before reporting a drug shortage, check FDA’s Drug Shortages Database to see if FDA is already aware of this shortage. If the drug is not in the Drug Shortages database, send a report to FDA through our public portal.

Submit a patient question or meeting request

As a patient, caregiver, or health care professional you can ask a question or request a meeting with the FDA. You can share disease experience or better understand the FDA’s regulatory work. Learn more about Patient Engagement Opportunities.

Report suspected criminal or counterfeit activity

FDA takes reports of suspect counterfeits seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. Use this form to report suspected criminal or counterfeit activity to FDA’s Office of Criminal Investigations.

Report unlawful sales of medical products

Use this form to report a website, social media account or retail store that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics.

Submit a Freedom of Information (FOIA) request

FOIA allows members of the public to request copies of records not normally prepared for public distribution. Use the FOIA online submission form to request such records or call 1-888-INFO-FDA (1-888-463-6332) for additional information. See FDA’s Frequently Asked Questions for Freedom of Information page to learn more about how to send a FOIA request.

Ask a general question or report another problem

Use the Contact CDER form to ask a general question. We try to respond to questions within 24-48 hours. You can also visit the CDER Contact Information page for more ways to contact us.

  • Content current as of:

    10/04/2024

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