USFDA And All The Details Regarding It

American regulatory authority

Sanjeyan N

25 days ago|3 min read

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The Food and Drug Administration of the United States (FDA or USFDA) is a federal agency that is part of the Department of Health and Human Services. The FDA regulates and supervises food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal food, and feed, and veterinary products.

USFDA

The FDA is in charge of enforcing the Federal Food, Drug, and Cosmetic Act (FD&C), as well as other laws and regulations such as Section 361 of the Public Health Service Act. Much of this regulatory work is unrelated to food or drugs and includes things like regulating lasers, cell phones, and condoms, as well as disease control in settings ranging from household pets to human sperm donated for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, whom the President appoints with the Senate's advice and consent.

The FDA's headquarters are located in the unincorporated town of White Oak, Maryland. Furthermore, the agency operates 223 field offices and 13 laboratories throughout the United States, the United States Virgin Islands, and Puerto Rico. Employees from the FDA began traveling to China, India, Costa Rica, Chile, Belgium, and the United Kingdom in 2008.

Headquarters

The FDA's headquarters are currently located in Montgomery County and Prince George's County, Maryland.

White Oak Federal Research Center

It is a federal research facility located in White Oak, TexasThe FDA has had employees and facilities on the White Oak Federal Research Center's 130 acres (53 hectares) in the White Oak area of Silver Spring, Maryland, since 1990. The FDA's 25 existing operations in the Washington metropolitan area, its headquarters in Rockville, and several fragmented office buildings were consolidated in 2001 when the General Services Administration (GSA) began new construction on the campus. 

In December 2003, the Life Sciences Laboratory, the first building, was dedicated and opened with 104 employees. As of December 2018, the FDA campus employed 10,987 people, who were housed in approximately 3,800,000 square feet (350,000 square meters) of space divided into ten offices and four laboratory buildings. 

The Commissioner's Office (OC), the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine's offices are all located on the campus (CVM).

The FDA expects a 64 percent increase in employees to 18,000 over the next 15 years, thanks to the passage of the FDA Reauthorization Act of 2017, and would like to add approximately 1,600,000 square feet (150,000 square meters) of office and special use space to their existing facilities. 

The National Capital Planning Commission approved a new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, depending on funding from the General Services Administration.

Funding and scope

The FDA regulates more than US$2.4 trillion in consumer goods or about a quarter of all consumer spending in the US. Food sales are $466 billion, drugs are $275 billion, cosmetics are $60 billion, and vitamin supplements are $18 billion. The FDA is in charge of overseeing imports, so a large portion of these costs is for goods imported into the US.

The FDA requested $4.36 billion in federal funding for fiscal year (FY) 2012, while the proposed 2014 budget is $4.7 billion. User fees account for about $2 billion of this budget. The majority of these fees, which are used to speed up drug reviews, are paid by pharmaceutical companies. The FDA requested $2.1 billion in the federal budget for the fiscal year 2008 (October 2007 to September 2008), an increase of $105.8 million over the amount it received in FY 2007.

The FDA announced in February 2008 that the Bush Administration had requested a budget of just under $2.4 billion for FY 2009, with $1.77 billion in budget authority (federal funding) and $628 million in user fees. 

The requested budget authority was $50.7 million higher than the funding for FY 2008, or about a 3% increase. Congress provided an emergency appropriation of $150 million for FY 2008 and another $150 million in June 2008.

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Sanjeyan N

YOU ARE THE ARTIST OF YOUR OWN LIFE. DON'T HAND THE PAINTBRUSH TO ANYONE ELSE.

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