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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

Emergent Suspends COVID-19 Vaccine API Manufacturing As US FDA Inspects Bayview Plant

After discovery of viral vector cross-contamination, AstraZeneca quit, J&J took control and the FDA launched inspection.

Coronavirus COVID-19 Vaccines

Industry ICH Proposal Would Limit International Regulatory Oversight Of Manufacturing Models

The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.

Manufacturing Quality

Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue

Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.

FDA Coronavirus COVID-19

Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic

Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.

Manufacturing Quality

Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

Manufacturing Quality

Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

Quality Compliance
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