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Jurisdictional conflicts
One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels impacts First Amendment issues, FDA must balance concerns about the public health with the right to free speech. Daniel Troy, Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.


Organization
Currently, the FDA is divided into five major Centers, each with its own origins and history:

• The Center for Drug Evaluation and Research (CDER)
• The Center for Biologics Evaluation and Research (CBER)
• The Center for Devices and Radiological Health (CDRH)
• The Center for Food Safety and Applied Nutrition (CFSAN)
• The Center for Veterinary Medicine (CVM)
• National Center for Toxicological Research (NCTR)
• Office of Regulatory Affairs (ORA)

FDA-Affiliated Organizations
• Joint Institute for Food Safety and Applied Nutrition
• National Center for Food Safety and Technology

CDER operations
The CDER, which regulates human pharmaceuticals, receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. In keeping with this, reviews are generally staffed by teams that are intended to come to consensus on decisions.

Within the CDER "Review teams" employs around 1,300 employees to approve new drugs. Additionally, the CDER employs a "safety team" has 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.

The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.


CBER operations
The CBER, which is the oldest operations center, oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy.

Above article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "The Food and Drug Administration (FDA)".

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