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FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance | King & Spalding - Vimarsana News

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance | King & Spalding

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute...

FDA Issues Draft Guidance Addressing Remote Regulatory Assessments - Life Sciences, Biotechnology & Nanotechnology - Vimarsana News

FDA Issues Draft Guidance Addressing Remote Regulatory Assessments - Life Sciences, Biotechnology & Nanotechnology

In March 2020, in response to the COVID-19 pandemic and associated health risks and travel restrictions, the Food and Drug Administration (FDA or the Agency) adjusted its field operations...

Source: mondaq.com