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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

US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

Quality Compliance

How Inspectorates Will Judge Quality Systems' Ability To Manage Manufacturing Changes

PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.

Manufacturing Quality

Pandemic Response Strains Global Biopharmaceutical Reactor Capacity

Distress grows as manufacturers wait for suppliers to boost production. One idea: stretch inventories by qualifying single-use bioreactors for reuse.

Biologics Gene Therapy

Final PIC/S Data Integrity Guidance Encourages Foolproof Approaches To Drug Manufacturing Data

Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.

Manufacturing Quality

Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter

Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.

Manufacturing Quality

Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later

Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.

Manufacturing Quality
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