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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

FDA Shortages Task Force Looks More Broadly To Tackle Root Causes

FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.

 

United States Manufacturing

FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Manufacturing Regenerative Medicine

The Quality Lowdown: Novartis/Sandoz Child-Resistant Packaging; Solvent Testing; Quality Metrics; Cell And Gene Therapy

Why did Novartis/Sandoz’s hospital blister packs have to be child-resistant? Why did two warning letters to Chinese firms follow promises of more, better testing? And should firms should consider volunteering for new FDA quality metrics programs (or not) and a pre-competitive industry collaboration on cell and gene therapies?

Manufacturing Quality

FDA Enforcement Initiatives Raise Visibility Of Supply Chain GMP Issues

US FDA is issuing “90-day” decisional letters at a quickening pace, publishing the inspectional results within another 30 days, and copying sponsors on warning letters, among other steps, to call their attention to GMP problems in their supply chains.

Quality Compliance

The Quality Lowdown: Cleaning Issues At Mylan, Blank Release Forms At API Plant In China, And More

Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”

Compliance Manufacturing

The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep

ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.

Quality Manufacturing
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