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On FDA’s Latest FSMA Guidance

The Food and Drug Administration recently issued three new guidance documents to help simplify compliance with Food Safety Modernization Act (FSMA) regulations and programs. On November 7, the agency released new draft guidance on registration of food facilities. The...

Drug Master File Submissions – An Overview

By Naitry Shah, EAS Intern (This article summarizes a White Paper on DMF submissions prepared by EAS Independent Consultant Albert Yehaskel.) Drug Master Files (DMFs) are detailed submissions to the Food and Drug Administration (FDA) that may be used to provide...