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 "FDA’s Center for Drug Evaluation and Research":

"… FDA approval. 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 "FDA’s Center for Drug Evaluation and Research":

"… testing 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 enforcement actions way down

By The Center for Public Integrity

Enforcement actions by the (FDA) markedly declined under the Bush administration

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

"… label abuses, limiting their effectiveness.Follow-up:A spokeswoman for the FDA’s Center for Drug Evaluation and Research told the Center that since companies have better complied after receiving …"

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Lack of adequate foreign drug oversight

By The Center for Public Integrity

The GAO called for improvement in the FDA’s Foreign Drug Inspection Program in 1998. A decade later, there's been little improvement.

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

"… tured at a Chinese facility, was contaminated. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a House panel in early 2008 that her agency faced “an ever-growing …"

"… ened in China. In response to a request for comment, a spokeswoman for the FDA’s Center for Drug Evaluation and Research noted the agency’s comments in response to a September 2008 GAO report i …"