Bowman Cox
Executive Editor
Latest From Bowman Cox
How US FDA Will Unleash Attack On COVID-19 Variants Once Global Consensus Is Reached
Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.
The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements
PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.
Newly Aligned Teams Sped US FDA’s Drug Quality Reviews Over Pandemic Hurdles
Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented inspections.
Preparing For The Return Of US FDA Inspections
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
How Operation Warp Speed Helps Clear Obstacles To COVID-19 Vaccine Production
Military workers filling in for quality control, manufacturers comparing supply lists, other measures to accelerate the manufacturing pace are noted in US congressional advisory group's report.
Hiding Cancer Drug Manufacturing Records Costs Fresenius Kabi $50M In US Settlement
It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.