The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA also plays a significant role in the Nation’s counter-terrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
The types Of FDA safety announcements include:
Early Communication About an Ongoing Safety Review :This type of communication is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.
Public Health Advisories: These advisories provide important drug safety information and recommendations of actions that can be taken by patients or caregivers to avoid or minimize harm from a drug. They are issued when FDA has information that would help doctors and patients make better treatment choices.
Letters to Health Care Professionals: These are letters—often referred to as “Dear Doctor” letters—that are developed by drug companies often with input from FDA. The letters educate health care professionals about new and important drug information.
Information for Health Care Professionals: Also referred to as a Healthcare Professional Information sheet, this information from FDA is for doctors, pharmacists, nurses, and other health care professionals. It contains an “alert” (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for health care professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the sheet.
FDA Drug Safety Newsletter: Aimed at health care professionals, this quarterly publication is designed to enhance communication of safety information after a drug is marketed. The newsletter raises awareness of adverse events and stimulates reporting of adverse events.
FDA Consumer Health Information: FDA offers timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including human drugs, drugs and feed for animals, medical devices, vaccines, blood, food, dietary supplements, and cosmetics.
FDA Drug Safety Podcasts: Podcasting is a method of publishing and syndicating audio broadcasts through the Internet. These provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. www.fda.gov/cder/drug/podcast/ default.htm FDA Drug Safety Newsletter Aimed at health care professionals, this quarterly publication is designed to enhance communication of safety information after a drug is marketed. The newsletter raises awareness of adverse events and stimulates reporting of adverse events. www.fda.gov/cder/dsn/default.htm FDA Consumer Health Information FDA offers timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including human drugs, drugs and feed for animals, medical devices, vaccines, blood, food, dietary supplements, and cosmetics.
Drug Product Recalls: FDA provides information on drug products that have been recalled due to manufacturing problems and/or safety concerns. In addition to information released to the public by a manufacturer using the normal media channels, FDA posts information about these recalled drug products at www.fda.gov/opacom/7alerts.html You can also sign up to receive e-mail notices of product recalls.
Patient Safety News: This is a televised series for health care professionals, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features safety information on new drugs, biologics, and medical devices.
