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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.

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In July 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry requiring manufacturers to provide certain manufacturing data on an annual basis.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

Proposed quality metrics program raises operability questions

By Guest Contributor  |    March 25, 2016
Previously in this blog series, we’ve discussed PhRMA’s main recommendation for a phased-in approach to the U.S. Food and Drug Administration’s (FDA) proposed quality metrics program, as well as...   Read More

Transparency and confidentiality in FDA’s proposed quality metrics proposal is key

By Sarah Spurgeon  |    March 15, 2016
In our last post on this topic, we discussed PhRMA member companies’ commitment to quality and introduced you to the U.S. Food and Drug Administration’s (FDA) proposed mandatory quality metrics...   Read More

The biopharmaceutical industry’s commitment to quality

By Camille Jackson  |    February 11, 2016
America’s innovative biopharmaceutical companies are leaders in innovation and quality—not just in research and development, but also in manufacturing technology. PhRMA’s member companies...   Read More

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