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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FDA

Latest Headlines

Latest Headlines

FDA warns manufacturer of failing to report corrections to its device disinfection system

The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.

New Jersey compounder indicted over unsanitary manufacturing

The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.

FDA in midst of updating endoscope labels implicated in 'superbug' infections

The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report.

Consumer group petitions FDA to pull generic antifungal med

Currently, there are several generics on the U.S. market of oral antifungal agent ketoconazole. But consumer advocacy organization Public Citizen is trying to change that.

Sagent brings production in-house after FDA finds fault with Indian CMO

Sagent Pharmaceuticals has transferred production of atracurium besylate injection to its own plant after the FDA spotted GMP problems at the CMO that was manufacturing the drug. The FDA observations relate to aseptic practices at Emcure Pharmaceuticals, an Indian manufacturer behind earlier recalls by Pfizer and Teva.

India's Sun Pharma recalls epilepsy treatment levetiracetam batch over failed dissolution tests

Sun Pharma issued a recall of 3,363 bottles of its levetiracetam extended-release drug for treating epilepsy in the United States after the tablets failed dissolution tests.

Lupin plant hit with Form 483 but continues to rack up approvals

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.

23andMe scores FDA OK to market genetic carrier test direct to consumers

23andMe nabbed FDA clearance to market its genetic carrier test directly to consumers, a big win for the company as it continues to get back in the agency's good graces and expand the reach for its genetic tests.

23andMe nabs FDA marketing clearance for direct-to-consumer genetic carrier test

23andMe scored FDA clearance to market its direct-to-consumer genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.

New studies shed light on power morcellator devices in surgical procedures

Months after the FDA recommended against using laparoscopic power morcellator tools for the "majority" of women undergoing certain gynecological procedures, two new studies are adding to a growing body of literature scrutinizing the devices.