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AGG Food & Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices by Device Manufacturers

On June 10, 2016, the Food and Drug Administration issued a draft guidance for industry and agency staff entitled, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” FDA will accept comments...more

FDA Releases Draft Guidance on UDI Requirements for Convenience Kits

On January 4, 2016, the Food and Drug Administration (FDA) released a draft guidance intended to clarify the Unique Device Identifier (UDI) labeling requirements for certain medical devices packaged together as “convenience...more

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