Latest From Bowman Cox
Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.
PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.
Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented 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.
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.
It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.