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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.

Latest From Bowman Cox

Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections

US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up. 

Manufacturing Quality

Children’s Hospital Resumes FDA-Funded Study Of PEG 3350 Pediatric Risks

New FDA assays may show whether polyethylene glycol laxative leaves toxic analytes and metabolites in children with chronic constipation – with potential implications for numerous other products.

Safety Ingredients

World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments

US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.

Manufacturing Quality

US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long

Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..

FDA Guidance Documents

US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long

Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, FDA officials tell the Pink Sheet.

Compliance Manufacturing

Emergent COVID-19 Vaccine Plant’s Quality Issues Draw Unusual Spotlight From US FDA Topsiders

Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.

Coronavirus COVID-19 Vaccines
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