U.S. Food and Drug Administration (FDA)

About FDA

The FDA is one of the United States government’s regulatory agencies. As the name implies, this agency oversees a broad range of topics that pertain to food and drugs. This includes most food and drink we consume and medications that are available over-the-counter or by prescription. Specific foods included are dietary supplements, bottled water, additives that are included in foods, and infant formulas. An exception to the foods regulated by the FDA includes meat from livestock, poultry and some egg products, which are regulated by the U.S. Department of Agriculture. The FDA regulates biologics which include vaccines, blood (such as donated blood), gene therapy products, tissue, and products that cause common allergies. Medical devices (pacemakers, surgical implants) and radiation emiting products (microwaves, x-ray equipment, etc) are regulated by the FDA as well. Regulation and safety of cosmetic products, food and medicine for animals, and tobacco products are also managed by the FDA.

The FDA is responsible for

  • Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
  • Protecting the public from electronic product radiation
  • Assuring cosmetics and dietary supplements are safe and properly labeled
  • Regulating tobacco products
  • Advancing the public health by helping to speed product innovations

FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.1

This responsibility includes enforcing laws that have been passed to ensure public health and protection of those who purchase products covered by the FDA. The 21st Century Cures Act is a recent law that was passed in December of 2016. This law was created to help accelerate the development of medical products and provide new innovations and research advancements to patients who need them in a way that is fast and efficient.

Organization of FDA

The FDA is a large organization with a broad reach to ensure the safety of American’s. The Office of the Commisioner is the head office within the organization, and below this are various offices and centers with specific roles and responsibilities. The largest centers and offices include:

  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Tobacco Products
  • Center for Veterinary Medicine
  • Oncology Center of Excellence
  • Office of Regulatory Affairs
  • Office of Minority Health & Health Equity

Learn more about patient engagement opportunities within the FDA

Center for Drug Evaluation and Research (CDER)

The Center for Drug Evaluation and Research (CDER) is an organization within the FDA. CDER works to ensure that drugs available to people living in the United States are both safe and effective. This is done through the regulation of prescription and over-the-counter drugs (medications) including biological therapies and generic drugs. Biologics are drugs that are developed in a living organism, often plant or animal cells. They are meant to treat, prevent, or diagnose medical conditions or diseases. The role of CDER covers beyond what is typically considered medications. CDER also oversees common personal care products including fluoride toothpaste, antiperspirant deodorants, dandruff shampoos, and sunscreens.

CDER has developed and maintains many initiatives to cover various needs within drug development and evaluation. A few of the initiatives are described below. You can learn more about CDER initiatives by visiting their website.

  • Rare Disease Cures Accelerator
    • Rare diseases have posed a unique challenge for those looking to improve research and treatment options while working towards cures. Through the Rare Disease Cures Accelerator, FDA is seeking ways to improve and increase research efforts despite the fact that rare disease communities have a smaller amount of patients than more common conditions. This includes ways to incorporate the patient’s perspective in clinical outcome assessment measures, ensuring patient needs are at the forefront of research.
  • Safety First Initiative
    • The Safety First Initiative is a key way to be sure that safety is evaluated at all points in the development and life of a drug. This is done through a pre-marketing drug review and by evaluating post-marketing safety.
  • Safe Use Initiative
    • The Safe Use Initiative is creating a collaborative effort to bring together various parts of the health care system to develop ways to reduce preventable harm from medications. This initiative works to limit and prevent errors that occur by those taking drugs, many of which are preventable. This includes people taking drugs in a way they are not intended to be used or receiving the wrong drugs or the wrong dose from their doctors or pharmacies.

Learn more about CDER by visiting the FDA website.

Information available on this page was adapted from FDA.gov

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