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

Boehringer Ingelheim still being dogged by Ben Venue plant

Boehringer Ingelheim is finding it difficult to get the stink of the troubled Ben Venue Bedford, OH, operations off its shoes. It closed the site last year and sold it last month but is still having to recall products produced there that might be contaminated.

Covidien acquires Sapheon ahead of FDA approval for vein adhesive

The Medtronic-Covidien integration team must be working overtime juggling not only existing products but also those in the deal pipeline. The pair hasn't slowed down at all--between them they have disclosed 5 acquisitions since their own merger announcement in mid-June, three of them this week alone.

ReShape targets U.S. approval as EU study shows major weight loss

ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.

NAFTA says FDA was in its rights to ban Apotex plants

It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.

FDA's 'Most Wanted Fugitives': The agency wants your help finding these bad players

You have heard about the FBI Top 10 Most Wanted list, and of the America's Most Wanted television show, but are you familiar with the FDA's list of Most Wanted Fugitives? Yes, the drug oversight agency has bad players who have fled that it would like to bring to justice. And it would like your help to do that.

UPDATED: FDA simplifies approval process for innovative devices lacking a predecessor

Truly innovative devices that do not have a substantially equivalent predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices. 

Rollout of openFDA continues with drug labeling, medtech adverse event APIs

Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.

FDA approves more innovative med tech, faster in first half

The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.

DEA tightens opioid dispensing rules amid controversy over abuse

On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.

FDA clarifies UDI requirements with new guidance

In an effort to bring clarity to the jargon-laden topic of unique device identification, the FDA released a straightforward, question-and-answer style guidance yesterday that tackles how to understand the requirements.