FDA Launches FEI Portal

On September 13, 2019, U.S. Customs and Border Protection (CBP) issued Cargo Systems Messaging Service (CSMS) #39785981 announcing the Food and Drug

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FDA Publishes Guidance on Mandatory Food Recalls

On November 5, 2018, the U.S. Food and Drug Administration (FDA) published a draft guidance for Industry and FDA Staff on mandatory food recalls.

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FDA Issues Guidance on Verification Systems Under the Drug Supply Chain Security Act

On October 24, 2018, the U.S. Food and Drug Administration (FDA) published its draft guidance on the verification systems that manufacturers, wholesale

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FDA Issues Supplemental Draft Guidance for Industry on Facility Registration

On August 20, 2018, the U.S. Food and Drug Administration (FDA) issued a supplemental draft guidance for the industry regarding food facility

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FDA Launches Export Listing Module for Processing FDA Regulated Establishment Requests

On July 9, 2018, U.S. Food and Drug Administration launched the Export Listing Module (ELM) to receive and process requests from company that wish to be

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Office of Management and Budget Releases Government Reform Plan

On June 21, 2018, the Office of Management and Budget (OMB) released the Government Reform Plan, which will reorganize several federal agencies.

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FDA Publishes New ACE Resource for Importers and Filers

On May 3, 2018, the U.S. Food and Drug Administration (FDA) published a quick reference guide to support the Supplemental Guide for the Automated

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FDA Issues Draft Guidance for the Definition of “Small Business” under the FSMA

On March 20, 2018, the U.S. Food and Drug Administration (FDA) issued guidance for industry regarding the definition of “small business” under Title 21 of

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USDA and FDA Reach a Formal Agreement on Cooperation and Coordination Between Agencies

On January 30, 2018, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) outlined an agreement on interagency cooperation

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FDA Releases Guidance on Foreign Supplier Verification Program

On January 24, 2018, the U.S. Food and Drug Administration (FDA) released a new draft guidance on the Foreign Supplier Verification Program (FSVP) for

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FDA Issues Guidance to Industry for Enforcement Discretion on the Food Safety Modernization Act

On January 5, 2018, the U.S. Food and Drug Administration (FDA) issued guidance for industry covering enforcement discretion on four of the seven

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FDA to Allow Additional Time for Co-Manufacturer Compliance under FSMA

On November 3, 2017, The U.S. Food and Drug Administration (FDA) issued guidance to allow co-manufacturers additional time to implement the Food Safety

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FDA Releases Food Safety Plan Builder for FSMA Requirements

On August 22, 2017 the U.S. Food and Drug Administration (FDA) published a news release regarding the release of a software tool, Food Safety Builder Tool

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FDA Announces New System Speeds FDA Import Decisions

On July 31, 2017 the Import Director for the U.S. Food and Drug Administration (FDA) issued a blog post analyzing data regarding processing times and

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FDA Introduces Five Import District Offices

On May 15, 2017 the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) announced a reorganization of the FDA Import Offices and

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