In Vivo is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Bowman Cox

Latest From Bowman Cox

Gottlieb: Valsartan API Crisis Spurs Drug GMP Revision

FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.

Manufacturing Quality

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing Quality

Proponents Of Quality Control Multi-Attribute Methods Tackle Adoption Challenges

Challenges ranging from fear of QC job loss to training requirements and discovery of surprise impurities confront effort to expand the use of powerful test methods for release of biopharmaceuticals.

Quality Manufacturing

The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Manufacturing Quality

US Visa Concerns Led ICH To Choose Canadian Meeting Site

The US, one of ICH’s original three member authorities, was spurned in favor of Canada for the pharmaceutical regulatory harmonization initiative’s next meeting in the region because of some participants’ difficulties obtaining US visas.

Manufacturing Legal Issues

Manufacturers, Compounders Clash As FDA Prepares Final Offer On Office Compounding

Pharmaceutical manufacturers and compounders are in opposition over the US FDA’s plans to carve out a place for pharmacies that want to keep physicians’ offices stocked with small amounts of product. Who will the agency disappoint this time?

Manufacturing Quality
See All
Advertisement
UsernamePublicRestriction

Register