Kate Hardey

Katten Muchin Rosenman LLP

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Latest Posts › Manufacturers

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Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

8/12/2025 / Comment Period , Executive Orders , Food and Drug Administration (FDA) , Manufacturers , Manufacturing Facilities , Onshoring , Pharmaceutical Industry , Public Meetings , Regulatory Reform , Supply Chain

Texas and Louisiana Serve Up New Laws on Food Product Labels and Disclosures

In a significant move toward greater labeling transparency and state oversight of food policy, Texas and Louisiana have enacted new laws requiring special labels and disclosures for certain food ingredients. Aimed at...more

7/28/2025 / Consumer Protection Laws , Disclosure Requirements , Food and Drug Administration (FDA) , Food Labeling , Louisiana , Manufacturers , New Legislation , Product Labels , Retailers , Texas

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

6/30/2025 / Comment Period , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements , Supply Chain

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