US FDA's First-Ever Countrywide Import Alert For Drugs Bans Mexican Hand Sanitizers
Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy.
You may also be interested in...
US FDA’s Donald Ashley recaps past year’s precedent-setting responses to COVID-19 pandemic in interview, while outlining return to pre-COVID priorities and traditional inspection-based oversight.
US FDA’s Donald Ashley recaps the past year’s precedent-setting responses to the COVID-19 pandemic in Pink Sheet interview, while outlining a return to pre-COVID priorities and traditional inspection-based oversight.
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.