Software is used extensively in medical devices for gathering, monitoring, and transmitting data to healthcare professionals and clinical technicians. Although software can be an extremely useful tool as a medical […] Read More >>
What are Clinical Trials? Clinical trials are a type of biomedical research that is conducted to help doctors and researchers learn more about health, diseases, and effective treatments in order […] Read More >>
One of Health Canada’s largest initiatives in the past few years has been the Self-Care Framework, which implements a different approach to regulating products, that are purchased and applied directly […] Read More >>
Health claims are integral to the success of Natural Health Products (NHPs) here in Canada. They provide products with a competitive edge in the marketplace and consumers with the information […] Read More >>
Health Canada has recently announced the initiation of the Stop Illegal Marketing of Drugs and Devices (SIM-DD) program. Health Canada’s introduction of this particular program is part of its contribution […] Read More >>
Supplemented Foods and Caffeinated Energy Drinks (CEDs) is a growing market within Canada. Primarily products in this category are ready-to-drink (RTD) beverages, Beverages mixes/concentrates or CED. However, temporary marketing authorization […] Read More >>
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 >>