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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.

Latest From Bowman Cox

More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Manufacturing Quality

Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Legislation Manufacturing

EMA Proposes Extending Remote QP Batch Certification Post-Pandemic

Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.

Distribution Manufacturing

PET Drugs Warning Letter: Implications For Decentralized Manufacture Of Personalized Medicines?

Brigham and Women's soldiered on as water gushed and microorganisms blossomed, potentially compromising sterility of injectable drugs, warning letter says. The focus was on PET drugs, but there could be implications for decentralized manufacture of personalized medicines like cell and gene therapies in health care settings.

Manufacturing Quality

US FDA Cracks The Door Open To Resolving Quality Issues After Approval

Draft guidance explains how agency intends to consider therapeutic context in benefit-risk framework to, in rare cases, set aside CMC issues for later resolution under "quality postmarketing agreements."

Quality Drug Approval Standards

House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad

Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal FDA coordination to prevent quality issues from causing drug shortages.

FDA Enforcement
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