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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 Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Quality Compliance

PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications

Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.

Compliance Manufacturing

The Quality Lowdown: FDA's Enhanced Drug Recall Authority

Opioid crisis gives US FDA something heparin crisis couldn’t: more drug recall authority in some cases. Meanwhile, Hanlim warning letter and Mercury Labs and Recipharm EU GMP non-compliance statements prove illuminating.

Recalls Manufacturing

Seqirus Completes Long Journey To Restore Afluria's Pediatric Indication

The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.

 

Manufacturing Vaccines

US FDA’s Pre-ANDA Advice On Correspondence, Meetings And Product-Specific Guidance

OGD's Lionberger offers advice on when to request a pre-ANDA meeting instead of controlled correspondence – and on the pros and cons of waiting for the agency to update product-specific guidance with the latest approaches.

Generic Drugs Drug Review

FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’

It’s all about change control and risk management, FDA compliance experts tell rapt audience at PDA/FDA conference when confronted with the common practice of planning deviations so that production won’t falter.

Compliance Manufacturing
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