Food and Drug Administration

By: Alternix

FDA Organization and Locations

FDA headquarters located in Montgomery County and Prince Georges County, Maryland.
The agency has 223 field offices and 13 laboratories across the United States, United States Virgin Islands, and Puerto Rico.
FDA employees are also posted in foreign countries such as China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Affairs.
FDA Building 66 houses the Center for Devices and Radiological Health.
FDA employees and facilities are located on 130 acres of the White Oak Federal Research Center in Silver Spring, Maryland.
The FDA campus has a population of 10,987 employees and approximately 3,800,000 square feet of space.
The FDA plans to increase its employees by 64% and add 1,600,000 square feet of office and special use space by 2035.
The Arkansas Laboratory in Jefferson, Arkansas serves as the headquarters of the National Center for Toxicological Research.
The Office of Regulatory Affairs (ORA) is divided into five regions and 20 districts, based on the geographic divisions of the Federal court system.
The Office of Criminal Investigations (OCI) was established in 1991 to investigate criminal cases related to FDA-regulated industries.

The FDA is responsible for overseeing $2.7 trillion worth of food, medical, and tobacco products.
The FDA's budget is funded by the federal government (54%) and industry user fees (46%).
Pharmaceutical firms contribute 75% of the FDA's drug review budget.
The FDA's regulatory programs cover a wide range of products, including emergency approvals (EUA) for medical countermeasures during public health emergencies.
Emergency Use Authorization (EUA) facilitates the availability and use of medical countermeasures during public health emergencies.
FDA regulations vary depending on the type of product and its potential risks.
The FDA regulates prescription drugs comprehensively, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety.
FDA regulation of cosmetics primarily focuses on labeling and safety.
The FDA enforces published standards through facility inspections, with inspection observations documented.

FDA regulates food and dietary supplements based on statutes enacted by Congress.
The FDA oversees the quality and labeling claims of substances sold as food in the US.
Substances regulated as food include foods, food additives, added substances, and dietary supplements.
Dietary supplements can include vitamins, minerals, herbs, amino acids, and enzymes.
The FDA has specific standards and means to address violations in each category.

FDA has different requirements for new drugs, generic drugs, and over-the-counter drugs.
New drugs undergo extensive scrutiny before FDA approval through a new drug application (NDA).
The Trump administration has worked to expedite the drug approval process.
Critics argue that FDA standards may not prevent unsafe or ineffective drugs from approval.
New drugs are initially available only by prescription, with a separate process for OTC status.

FDA's Office of Prescription Drug Promotion (OPDP) reviews and regulates prescription drug advertising.
OPDP conducts surveillance activities and issues enforcement letters to pharmaceutical manufacturers.
Advertising and promotion for OTC drugs are regulated by the Federal Trade Commission.
FDA engages with third-party enforcer-firms for regulatory oversight.
FDA expects pharmaceutical companies to comply with advertising and promotion regulations.

Reference	URL
Glossary	https://www.alternix.com/blogs/glossary-of-terms/food-and-drug-administration
Wikipedia	http://en.wikipedia.org/wiki/Food_and_Drug_Administration
Wikidata	https://www.wikidata.org/wiki/Q204711
Knowledge Graph	https://www.google.com/search?kgmid=/m/03wh5r