US Food and Drug administration

US Food and Drug administration logo

FDA is an agency within the Department of Health and Human Services and consists of six product centers, one research center, and two offices. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.

FDA is responsible for

·         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

·         Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health

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.

International programs:

Globalization: Geographic Programs

Globalization is a fact of 21st century economic life. It has resulted in United States markets being composed of a myriad of imported goods that our consumers want and need. Based on the volume of imported products from specific areas, problems that have been associated with products over the years, and value to be derived from leveraging the activities and resources of trusted foreign counterpart regulatory authorities, FDA has identified China, India, the Middle East, Europe, and Latin America as areas in which to establish a permanent in-country presence.

Harmonization and Multilateral Relations

Recognizing the considerable synergy between its domestic policy and its international policy priorities, FDA is sharpening and focusing its planning for enhanced alignment of FDA and international standards. In recent decades, great changes in the world economy, together with expanded working relationships of regulatory agencies around the globe, have resulted in increased interest in international harmonization of regulatory requirements. Increased international commerce, opportunities to enhance public health through cooperative endeavors, and scarcity of government resources for regulation have resulted in efforts by the regulatory agencies of different nations to work together on standards and harmonize their regulatory requirements. Such harmonization enhances public health protection and improves government efficiencies by reducing both unwarranted contradictory regulatory requirements and redundant applications of similar requirements by multiple regulatory bodies. FDA's goals in participating in international harmonization are:

·         To safeguard global public health, 

·         To assure that consumer protection standards and requirements are met, 

·         To facilitate the availability of safe and effective products, 

·         To develop and utilize product standards and other requirements more effectively 

·         To minimize or eliminate inconsistent standards internationally.

FDA’s harmonization efforts are intended to pool regulators’ resources in developing standards for public health protection; reduce industry’s compliance costs in the global market, and minimize impediments to bringing safe food and safe and effective treatments to consumers and patients around the world.

Capacity Building

U.S. FDA’s technical cooperation and capacity-building efforts are related to the development, utilization, and enforcement of international scientific regulatory standards that help assure globally the efficacy, safety, wholesomeness, and quality of FDA-regulated products.

Given the accelerating challenges of a globalized supply chain, the U.S. FDA collaborates with regulatory counterparts of other countries, multi-lateral organizations, other U.S. government agencies and global initiatives to improve regulatory infrastructures, preventive controls and production practices.

In support of global harmonization efforts, technical cooperation and capacity building activities include sharing information about applicable regulatory disciplines and import requirements; assisting with strengthening detection, surveillance and assessment systems; and designing and developing data/information systems and platforms. These efforts are provided through numerous modalities, including cooperative agreements with multilateral agencies; in-class and train-the trainers programs; web-based modules; publications; and other multi-media materials.

To view the detailed organization chart click here. 

Source: FDA official website