Publications

Hogan Lovells Publications

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the ...

Hogan Lovells Publications

FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation

The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained...

Hogan Lovells Publications

FDA announces public meeting on modernizing food standards of identity

The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards...

Hogan Lovells Publications

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization...

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major...

Hogan Lovells Publications

FDA announces reinspection and VQIP fees for Fiscal Year 2020

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the...

Hogan Lovells Publications

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’...

Hogan Lovells Publications

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in...

Hogan Lovells Publications

FDA Issues Draft Guidance on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the...

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