On February 11, 2019, FDA Commissioner Dr. Scott Gottlieb announced that the regulatory framework for dietary supplements is expected to change. It has been determined that changes are necessary due […] Read More >>
There is an undeniable truth that Artificial Intelligence (AI) is the next frontier for the healthcare industry. Several sources have already pegged the market to be worth $36.1 billion by […] Read More >>
FDA Issues New Guidance Documents for Nutrition and Supplements The FDA has updated the Nutrition and Supplement Facts Labels. The update was in response to comments received on the draft […] Read More >>
The Safe Food for Canadians Regulations (SFCR) handbook was recently published to help businesses understand the requirements and the implications they may have. Now that 2019 is just around the […] Read More >>
On November 5, 2018, the Federal Register revealed new guidance on Nutrition and Supplement Facts Labels with questions and answers related to the Compliance Date, Added Sugars, and Declaration of […] Read More >>
Deadline for GTE Attestation: November 14, 2018 It’s been almost a year since the safety review of green tea extract was released by Health Canada, and November 14, 2018, is […] Read More >>
In July of this year, the FDA announced new innovative approaches that demonstrate safety and efficacy for nonprescription drug products while expanding consumer access to more products. These innovative approaches […] Read More >>
Health Canada recently gave updates to 27 monographs and provided notice of extended licence processing timelines. Read more to ensure compliance with the latest NNHPD updates. 1. Green Tea Extract […] Read More >>
Last weekend’s Canadian Health Food Association (CHFA) East 2018 Conference, Canada’s largest conference and trade show for the natural health, organic and specialty food industries. There were two days of conversations […] Read More >>
Amazon has announced requirements requiring total compliance with Health Canada’s regulations for all non-prescription drugs, supplements, and natural health products (NHPs) sold in Canada through its platform. The Amazon compliance […] Read More >>
ISO Prepares for FDA’s Proposed Overhaul of Medical Device Quality System Regulation Late in February 2018, the FDA announced that as part of global harmonization efforts around quality management systems, […] Read More >>
On August 17, the industry comment period for the FDA’s Medical Device Safety Action Plan closed. Back in April of this year, the FDA announced the new Plan, which is […] Read More >>
Failing to conduct proper regulatory due diligence can be likened to failing to conduct a proper home inspection before purchasing a home. We have all heard of home buyers who […] Read More >>
At dicentra, we get many requests for assistance with new product development and formulation changes. Developing a new product or adjusting a formulation can be one of the most satisfying […] Read More >>
In May 2018, the Bill S-5 received Royal Assent for Canada’s new Tobacco and Vaping Products Legislation (TVPA). With this update, all vaping products that are not subject to the Food […] Read More >>
Prop 65, California’s right-to-know law that requires a clear and reasonable warning for chemicals known to cause cancer or reproductive harm, finds that coffee does not require a cancer warning. […] Read More >>
Safe Food for Canadians Regulations under SFCA comes into force on January 15, 2019. Are you ready? On June 13, 2018, the Minister of Health announced the publication of […] Read More >>
On May 23, 2018, Health Canada published two new Adverse Reactions Guidance Documents for Marketed Health Products (including Natural Health Products or NHPs) and their reporting. Both come into effect immediately. […] Read More >>
The global veterinary and animal equipment market is growing with an estimated compound annual growth rate (CAGR) of 8.0% in this 2015 to 2020 time period. This growth is largely […] Read More >>
The Canadian Food Inspection Agency (CFIA) has released updated guidance on the proposed Safe Food for Canadians Act (SFCA) and its associated regulations. Included in the release is a step-by-step […] Read More >>
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