What the New FDA PreCheck Program Means for Drug Manufacturers
Introduction Announced on August 7, 2025, the FDA PreCheck program is a new initiative aimed at strengthening the domestic pharmaceutical
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August 13, 2025
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[blog_list]
FDA Proposes Compliance Extension And Releases New Tools For Food Traceability
The FDA food traceability rule is once again in the spotlight. On August 6, 2025, the U.S. Food and Drug
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August 7, 2025
FDA Chemical Screening: What The New EDT Tool Means For Food Safety
The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety
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July 31, 2025
Senators Propose Bill To Eliminate Self-affirmed GRAS Loophole
A new bill introduced in the U.S. Senate could significantly alter how food ingredient safety is assessed, especially when it
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July 24, 2025
FDA approves gardenia blue as Red No. 3 faces phase-out
The U.S. Food and Drug Administration (FDA) has approved gardenia blue, a plant-derived color additive, for limited use in certain
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July 18, 2025
How the SAFE Sunscreen Act Could Change FDA Compliance
Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On
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July 18, 2025
Health Canada issues interim report on sodium targets for processed food
Introduction Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard
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July 9, 2025
FDA Updates Food Labeling Compliance Program
The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements
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June 26, 2025
How to Comply with the FDA’s NDI Notification Process
If you’re planning to introduce a new ingredient into your dietary supplement formula for the U.S. market, the FDA NDI
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June 13, 2025
Class II NHP submissions: What Health Canada’s New Workload Rules Mean For You
Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed
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June 9, 2025
FDA Approves Natural Food Colors for Safer Use
The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to
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May 12, 2025
FDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
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May 12, 2025
FDA Front-of-Package Labeling Deadline Extended
FDA Front-Of-Package Labeling Comment Period Extended The U.S. Food and Drug Administration has extended the comment period for its proposed
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May 11, 2025
Health Canada electronic filing updates: Key changes in 2025
If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want
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May 9, 2025
Health Canada’s April 2025 Updates on the Medical Device Shortage List
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed. On
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April 29, 2025
Why The FDA Is Phasing Out Petroleum-based Synthetic Dyes
The FDA’s decision to phase out petroleum-based synthetic dyes is poised to bring major change to food manufacturers across the
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April 27, 2025
FDA announces ESG NextGen launch for industry submissions
FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now
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April 17, 2025
EFSA Opens 2025 Call for Novel Food Advice to SMEs
Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so,
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April 13, 2025
Health Canada Releases Consultation on Co-Packaged Drug Products
Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation. The guidance explains
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March 29, 2025
FDA Releases Cosmetic Facility & Product Registration Summary
On March 13, 2025, the U.S. Food and Drug Administration (FDA) released its first public summary data on the mandatory
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March 26, 2025
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July 14, 2025