Pink Sheet 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


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.
Set Alert for Articles By Bowman Cox

Latest From Bowman Cox

FDA Contract Awards In Brief: Regenerative Medicine, eCTD, Reg Science

Contracts US agency awarded as fiscal year 2017 came to a close include one to Nexight for a regenerative medicine standards development process, another to Lorenz to manage eCTD submissions – and 26 more for regulatory science R&D.

Regenerative Medicine Compliance

Gottlieb: Why FDA Must Help Restore Puerto Rico's Pharma Sector

FDA commissioner underscores importance of restoring full production in Puerto Rico, where nearly 10% of all pharmaceuticals consumed in the US are made. Some plants have partially resumed operations under generator power, he notes, but the full recovery that at some point will be needed to prevent shortages will require restoring the island's power grid.

Manufacturing Puerto Rico

FDA Focusing On Drug Shortage Risks From Puerto Rico Hurricane

FDA has identified more than 40 high-priority drug products from at least five companies and is offering assistance to resume operations, including 'coordinating transport of certain critical drugs out of Puerto Rico.'

Manufacturing Puerto Rico

FDA Works To Encourage Office-Use Compounding In Advance Of Legislation

FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.

Quality Manufacturing

Merck Cyberattack Recovery: Congress Scrutinizes Manufacturing Problems

A House committee has requested a briefing from Merck on the June 27 NotPetya malware attack that has impeded manufacturing operations, and on the pharmaceutical company's subsequent remediation efforts. Meanwhile, a pharmaceutical industry group is bringing experts together to brainstorm on cyber security best practices.

Cybersecurity Manufacturing

Puerto Rican Pharma Plants Prepare For Hurricane Maria

Pharmaceutical companies race to prepare manufacturing facilities in Puerto Rico, many of which date back to the 1980s and 1990s, for the arrival of Hurricane Maria.

Manufacturing Puerto Rico
See All