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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

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.

Manufacturing Coronavirus COVID-19

A Pandemic Template For Swift Approval? Veklury Stability Questions Deferred For Later Study

The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.

Manufacturing Quality

Pandemic Will Continue Limiting US FDA Inspections In Driving FY 2021 Drug GMP Warnings

FDA historically has based 100% of drug adulteration warning letters on inspections but COVID-19-related travel restrictions began changing that in FY 2020, when 2% of drug GMP warning letters were based on testing import samples. The change became even more pronounced in the first two months of FY 2021, with 59% of actions related to sample testing and 41% to inspections.

FDA OTC Drugs

Operation Warp Speed Angles For Greater Role In Pfizer COVID-19 Vaccine Manufacturing

Government offers help securing supplies in return for another 100 million doses by Q2. That would mean abandoning Pfizer’s preferred arms-length relationship.

Coronavirus COVID-19 Manufacturing

Pandemic Will Limit Role Of US FDA Inspections In Driving FY 2021 Drug GMP Sanctions

Look for alternative approaches like sample testing, remote records review and reliance on trusted host nation authorities to fill many inspection gaps – except for OAI re-inspections. Meanwhile, post-emergency planning begins.

Quality Compliance

Pfizer’s Expected 2020 COVID-19 Vaccine Production Fell By 50% After Scaleup Delays

Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.

Vaccines Manufacturing
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