Based: Washington, DC
Budget: $3.2 billion
Comissioner: Margaret Hamburg

Description: The U S. FDA is the world's premier scientific, regulatory, and public health agency. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 8,000 employees in 2006. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories. The FDA also monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person.

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Latest Headlines

Latest Headlines

Troubled India's Wockhardt sees third U.S. drug recall in as many months

India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.

UPenn study finds FDA regulates devices optimally, European regulators are 'too lax'

The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.

TCM-based oncology candidate wins U.S. FDA nod for PhIII, Xinhua says

A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.

FDA issues guidance to help companies meet their first UDI direct marking deadline

Industry is barreling toward its first direct marking requirement under the FDA's unique device identification (UDI) initiative. To help companies comply with the requirements, the agency released a Q&A-style guidance on the topic.

Pharmacy groups plead with FDA for more time to get on board with track-and-trace

The Drug Supply Chain Security Act, passed by Congress in 2013, lays out a timetable for companies to be able to comply with the so-called track-and-trace rules that would allow the FDA to more easily locate recalled products and to protect against counterfeits.

Pharmacies want more time to comply with track-and-trace rules

This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.

FDA slaps U.S. drugmaker over drug testing issues

When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.

Bill introduced in Congress to encourage faster premarket device reviews

Sens. Richard Burr (R-NC) and Al Franken (D-MN) recently introduced legislation that encourages the FDA to review medical devices in the "least burdensome" manner, as required under the FDA Modernization Act of 1997.

FDA hints it will show 'additional flexibility' when it comes to approving device clinical trials

The FDA released an overview of its considerations and process for reviewing so-called investigational device exemptions, which give researchers permission to test developmental devices on humans.

FDA issues safety warning to cardiologists based on troubling post-market data

The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.