The Quality Lowdown: On Redeploying Inspectors, API Suppliers Thanks To Coronavirus
US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
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2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic
Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.
US FDA Freezes Inspections And Outside Meetings. Will Review Goal Dates Stay Put?
Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.