The FDA (U.S. Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services that is responsible for protecting and promoting public health through regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, medical devices, and electronic products that emit radiation.
The FDA was created in 1906 with the passage of the Pure Food and Drugs Act.
In 1927, the agency was reorganized as the Food, Drug, and Insecticide Administration and given increased authority to regulate cosmetics and medical devices.
In 1938, the Federal Food, Drug, and Cosmetic Act gave the FDA jurisdiction over food color additives and medical devices, and required new drugs to be proven safe before they could be sold.
In 1976, the Medical Device Amendments gave the FDA increased authority to regulate medical devices.
In 1983, the Orphan Drug Act provided incentives for the development of drugs for rare diseases.
The FDA has continued to evolve and expand its reach, particularly in response to new technologies and emerging health threats.
Recent efforts have focused on improving food safety, addressing opioid addiction, and developing a regulatory framework for products that use cannabis and cannabis-derived compounds.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The National Institutes of Health (NIH) is the largest biomedical research agency in the world, providing leadership and funding in the pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health.
The Centers for Disease Control and Prevention (CDC) is a national public health agency in the United States that conducts research and provides guidance on preventing and responding to infectious diseases, chronic diseases, injuries, and other health conditions.
The FDA provides guidance documents and regulations to help regulated industries comply with federal laws and regulations.
The FDA reviews and approves new pharmaceutical drugs for safety and efficacy, and monitors drugs on the market for safety concerns and unexpected side effects.
The FDA sets standards for the safety and quality of food products sold in the United States, and conducts inspections of food facilities to ensure compliance with regulations.
The FDA reviews and approves medical devices for safety and effectiveness, and monitors devices on the market for safety concerns and malfunctions.
The FDA regulates the manufacture, distribution, and marketing of tobacco products in the United States, and aims to reduce smoking rates and tobacco-related health problems.
The FDA is a federal agency of the United States Department of Health and Human Services that is responsible for protecting and promoting public health through regulation and supervision of various products including food, drugs, medical devices, and tobacco products.
The FDA employs a range of regulatory and enforcement tools to protect public health, including approving safe and effective products, monitoring products on the market for safety concerns, conducting inspections of regulated facilities, issuing guidance documents and regulations, and taking enforcement action when necessary.
Yes, the FDA has the authority to ban products that are unsafe or do not meet regulatory standards.
The FDA approval process for drugs involves multiple phases of clinical trials to test safety and efficacy, as well as a review of data and labeling information. The process can take several years and involves collaboration between the FDA and drug manufacturers.
No, the FDA is funded primarily by federal appropriations, not the pharmaceutical industry. However, the agency does receive fees from drug manufacturers for certain services, such as the review of new drug applications.