Bowman Cox
Executive Editor

Latest From Bowman Cox
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.
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.
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.
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Draft guidance explains how agency intends to consider therapeutic context in benefit-risk framework to, in rare cases, set aside CMC issues for later resolution under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."
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.
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 US FDA coordination to prevent quality issues from causing drug shortages.