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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.
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Latest From Bowman Cox

Why Data Integrity Concerns Led Fresenius To Back Away From Akorn Deal

Tipped off by whistleblower, Fresenius reviewed data integrity audits that led it to back away from plans to acquire Akorn, firm tells court. It’s a case with lessons for any pharmaceutical company that wants to ensure its own data integrity – and that of its business partners.

Manufacturing Quality

Removal Of Outdated FDA Inspection Scheduling Rule Blocked By A Few Individuals

It may have seemed like a ‘no brainer’ for FDA to immediately remove the outdated two-year inspection requirement for biologics facilities, but the agency will trudge through the full rulemaking process instead owing to what it called ‘significant adverse comment.’ Such a slow turning of bureaucratic gears might not bode well for the Trump administration’s regulatory reforms.

Manufacturing Biologics

CMC Regulatory Updates In Brief: Complete Response Tallies And Guidance On Inhalers, Supplements, Liposomes And H2O2

US FDA attributes 12% of last year's complete responses to manufacturing facility issues. Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for liposomes drafted in 2015, while UK MHRA cautions firms against relying on VHP to sterilize isolator parts.

Manufacturing Quality

As Saline Shortages Persist, Providers Pin Hopes On Feds Demanding Backup Manufacturing Capacity

As market forces, seasonal flu and extreme weather cause US shortages of intravenous saline solutions to persist, providers writing in NEJM are heartened by idea that federal Homeland Security Department could step in to require manufacturing redundancies. Will industry solve the problem before it becomes a matter of national security?

Manufacturing Compliance

Proposed Legislation Would Help FDA Stop Illicit Opioids At Border -- And More

US FDA would gain more of the ability it seeks to interdict illicit opioids at the border under legislation proposed by House Energy & Commerce Committee's top Democrat. But would there be collateral damage to the legitimate pharmaceutical industry?

Distribution Compliance

FDA Quality Office Looks Back At 2017: Reviews Accelerated, Inspections Realigned

US agency's Office of Pharmaceutical Quality continues to accelerate review and inspection processes, according to its first annual report. Meanwhile, the office's signature quality metrics initiative goes underground.

United States Compliance
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