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Food and Drug Administration (FDA) › Rulemaking Process › Supply Chain

Hogan Lovells

FDA Issues Proposed Rule Extending Compliance Date for Food Traceability Rule

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The United States Food and Drug Administration (“FDA”) recently issued a proposed rule to extend the compliance date for the final rule “Requirements for Additional Traceability Records for Certain Foods” (the “Traceability...more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

Mintz - Health Care Viewpoints on

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited FSMA Final Rules Published

Faegre Drinker Biddle & Reath LLP on

On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls...more

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