FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
... Read moreThe U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
... Read moreRecent regulatory activity in the United States is drawing renewed attention to sunscreen compliance. In a new announcement, the FDA
... Read moreThe U.S. Food and Drug Administration has announced new actions aimed at improving recall effectiveness following an investigation into an
... Read moreMembers of the U.S. House of Representatives have introduced the Childhood Diabetes Reduction Act of 2025, a bill that would
... Read moreThe Canadian Food Inspection Agency (CFIA) has issued a new industry notice outlining the final steps required before the Feeds Regulations 2024 becomes fully
... Read moreRed tape continues to create challenges for companies working within Canada’s food, agriculture, and plant industries. While strong safeguards remain essential, many
... Read moreHealth Canada has lowered the permitted level of caffeine and caffeine citrate in cola type beverages from 200 ppm to
... Read moreHealth Canada released a new modification to the List of Permitted Supplemental Ingredients that expands when and how caffeine can be used
... Read moreHealth Canada has launched a new national consultation that could reshape how infant foods for special dietary purposes are assessed
... Read moreNNHPD has introduced two new regulatory tools designed to simplify the natural health product submission process and give you more
... Read moreA new proposal in the U.S. Senate could bring mandatory GRAS notification to the forefront of food regulation, changing how
... Read moreEFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
... Read moreHealth Canada has officially postponed the implementation of its proposed NHP cost recovery fees, which were initially expected to take
... Read moreIf your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
... Read moreFDA confirms NMN is lawful in dietary supplements after industry pressure. Learn what this means for your business and compliance strategy.
... Read moreFDA proposes ending the self-affirmed GRAS pathway. Learn what this means for your business and how to stay compliant.
... Read moreThe FDA adverse event reporting dashboard for cosmetic products is now live, offering businesses and consumers real time access to
... Read moreOn September 4, 2025, Health Canada released Version 4.0 of the Good Manufacturing Practices (GMP) Guide for Natural Health Products
... Read moreBusinesses in Canada have long raised concerns about red tape in Health Canada regulations, from outdated rules to lengthy approval
... Read moreThe de minimis rule is ending in the U.S. Learn what this means for compliance, shipping costs, and your regulatory strategy.
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