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Bowman Cox
Executive Editor
Latest From Bowman Cox
Vega Life Sciences Warning Letter Shows Difficulty Of Applying Drug GMPs To API Solvent Recyclers
Recycling offers economic and environmental benefits, but risks introducing potentially carcinogenic impurities. Company barred from US market.
US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists
With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
Protecting Drug Manufacturing From COVID: US FDA Offers Directions
Guidance provides agency’s expectations for keeping virus out of drugs and facilities by protecting, monitoring, and excluding workers.
Hope Is Not A Plan: Manufacturing COVID-19 Therapeutics
Duke-Margolis discussion emphasizes biopharma sector must quickly collaborate on manufacturing coronavirus therapeutics likely to be authorized or approved in coming months.
Drug Quality Focus On Asia, OTCs Supported By US FDA's Second GMP Data Report
OTCs and other "no-application" products remain a drag on overall quality, agency finds in annual quality report, while India and China continue to pose challenges.
Protecting Rx Manufacturing From COVID: US FDA Offers Directions For Firms
Guidance provides agency’s expectations for keeping virus out of drugs and facilities by protecting, monitoring, and excluding workers.