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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.
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Latest From Bowman Cox

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

FDA’s New ‘Site Engagement’ Program Aims To Avert Quality-Related Drug Shortages

US FDA office that surveils drug manufacturing facilities invites sites on the cusp of failure for “engagements” in which they talk about how to turn things around. The agency says there’s no pressure – these site engagements aren’t enforcement actions and they’re completely voluntary.

Compliance Quality

The Next New Thing In FDA Inspections: Poor Root Cause Investigations

Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.

Manufacturing Quality

It’s Time For The Feds To Get Into Drug Manufacturing, Senator Warren Says

Warren's proposed legislation aims to bring down prices and stabilize supplies by establishing government competition to generic drug monopolies.

Generic Drugs Biosimilars

FDA Looks To Strengthen, Speed Drug Reviews With Flow Of Quality Data

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Manufacturing Outlook 2019

FDA Looks To Strengthen, Speed Drug Reviews With Flow Of Quality Data

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Manufacturing Outlook 2019
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