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We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

Fact Check Friday: Biopharmaceutical company communications with payers

By Andrew Powaleny  |    April 29, 2016
Today, we’re examining how and what biopharmaceutical companies communicate with payers about a medicine prior to its approval by the U.S. Food and Drug Administration (FDA). MYTH:...   Read More

Phased-in approach offers best hope for FDA’s proposed quality metrics program

By Camille Jackson  |    April 7, 2016
In July 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry requiring manufacturers to provide certain manufacturing data on an annual basis. The FDA’s Center for...   Read More

Research doesn’t end on a medicine’s approval

By Andrew Powaleny  |    March 16, 2016
Research is a critical part of the development of new medicines, but it doesn’t stop once the medicine is approved by the U.S. Food and Drug Administration (FDA).  In fact, that’s when...   Read More

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