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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads Citeline's coverage of pharmaceutical manufacturing. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to manufacturers and their quality organizations. Bowman has followed various energy, environmental and health care sectors, writing news for pharmacists, chemists, engineers, lawyers and other professionals. He has moderated and presented at industry and journalism conferences, and has a background in product development, having helped launch publications, conferences and a journalism association. Bowman has a passion for connecting with professional communities, discovering their truths, telling their stories and helping them learn from each other.

Latest From Bowman Cox

What The FDA Looks For When Inspecting Sites Soon After Approving Drugs

Quietly issued internal Compliance Program guidance on post-approval inspections suggests official action could be indicated when it turns out some “established conditions” are missing from applications. Whether the rate of these inspections will need to increase in the wake of the pandemic, particularly as applications for complex dosage forms and new manufacturing modalities multiply, remains to be seen.

Quality Drug Approval Standards

Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

Manufacturing FDA

Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

Quality Safety

The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

Compliance Manufacturing

Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.

Manufacturing Quality

US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways

FY2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.

Manufacturing Quality
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