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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

Manufacturing Regulatory Updates In Brief

FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.

Quality Manufacturing

FDA Aligns New Pharmaceutical Inspectorate Into Six Divisions

US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.

Compliance Manufacturing

US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?

Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.

Manufacturing Quality

Reducing Serialization's Impact On Capital Costs, Equipment Effectiveness

Expert shares cost-saving tips on compliance with US Drug Supply Chain Security Act's serialization mandate.

Distribution Manufacturing

European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs

The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.

Manufacturing Quality

FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

Manufacturing Quality
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