Center for Drug Evaluation and Research

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The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective.

The CDER 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.

The current Acting Director is Dr. Steven Galson.

[edit] Role of Advisory Committees

CDER submits requests for advice to many different Advisory Committees. These committees, composed of experts in their respective fields, provide non-binding advice to CDER about the advisability of approving particular drugs.

There are sixteen advisory committees functioning within CDER: