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FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

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