FDA reaches agreement with firm that produced troubled heart drug

The U.S. Food and Drug Administration last week announced a little-noticed tentative agreement setting conditions under which a troubled pha

Excerpts from this story referencing "Center for Drug Evaluation and Research":

"… oval. Commenting on the agreement, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “The FDA will not allow manufacturers to put the public’s healt …"

Most drug trial results analyzed by FDA hidden from view

By Naseem Miller

Before a new drug finds its place on pharmacy shelves or a new device lands in the hands of a surgeon, it goes through a long and complex ap

Excerpts from this story referencing "Center for Drug Evaluation and Research":

"… and animal studies before the drugmaker submits an application to FDA’s Center for Drug Evaluation and Research. If it gets the agency’s green light, then the human clinical trials beg …"

FDA: A shell of its former self

By M. Asif Ismail

The Food and Drug Administration lacks the power to regulate pharmaceuticals and keep you safe

Excerpts from this story referencing "Center for Drug Evaluation and Research":

"… use to comply with its warning letters]."Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, acknowledged in 2000 that the FDA did not have the resources for a scient …"

"… FDA expects to collect more than $284 million in user fees this year.) The Center for Drug Evaluation and Research, the largest of the FDA's five centers with responsibility for assuring th …"

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FDA failure to ensure drug safety

By The Center for Public Integrity

Vioxx dangers raise questions about FDA's ability to monitor drugs

Excerpts from this story referencing "Center for Drug Evaluation and Research":

"… e numbers of avoidable deaths and injuries.” A spokeswoman for the FDA's Center for Drug Evaluation and Research told the Center that the agency's job is "to balance a drug's benefits aga …"