US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists
Executive Summary
With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
You may also be interested in...
Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card
Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.
Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card
Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.
Time To Focus On GMP Activities Deferred By Pandemic, CDER Compliance Director Says
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.