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Updated April 2006

Patient Involvement

Patient Participation in FDA Regulatory Issues

• Patient Representative Program, The Patient Representative is responsible for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease.
• Drug Development Patient Consultant Program This program incorporates the perspective of patient advocates into the drug development process allowing them an opportunity to participate in the FDA drug review regulatory process.
• Patient Representatives to FDA Advisory Committees Frequently Asked Questions for Patient Representatives
• Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting
• The Value of Patient's Perspective in the FDA Decision Process, Sharon Smith Holston, Deputy Commissioner, FDA,  10th IMS International Symposium, November 3, 1997

Articles

• Getting Outside Advice for "Close Calls" A primer on FDA Advisory Committees
• Advisory Committees: Critical to the FDA's Product Review Process The role of FDA Advisory Committees in product regulation
• Advisory Committees: FDA's Primary Stakeholders Have a Say The history and role of consumer and patient representatives on FDA Advisory Committees.
• Bringing Real Life to the Table: Patient Reps Help FDA Review Products Representing the patient's perspective in FDA Advisory Committee meeting.
  

Regulatory Information

• Treatment IND definition and discussion

Related Information

• ClinicalTrials.gov, the National Institutes of Health Clinical Trials Database
• The MedWatch Program enhances the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice to help identify significant health hazards associated with these products.   Visit the MedWatch page and learn how to work with your health care professional to report possible adverse reactions. The patients identity is kept confidential.  This section also contains extensive information about the safety of medical products, with summaries of safety-related labeling changes presented on a month-by-month basis.
• HIV/AIDS Program
• Cancer Liaison Program
• Index to Drug-Specific Information, a list of consumer drug information sheets that provide basic information about medications approved by the FDA since 1998. This Index does not include all FDA approved drugs, only those with consumer Information Sheets and Pages. Please use Drugs@FDA to search for information on a drug not found in the Index.
• Food & Drug Interactions [PDF] . Many medicines have powerful ingredients that interact within the body in different ways, and diet and lifestyle can sometimes have a significant impact on a drug's ability to work in the body. Certain foods, beverages, alcohol, caffeine can interact with medicines. This brochure (in PDF format) has information about possible interactions between many common prescription and nonprescription (over-the-counter) drugs with food, alcohol and caffeine. National Consumers League, 1998.

PDF documents may be read with a free copy of the Adobe Acrobat Reader.

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