On July 17, 2023, the FDA announced the successful conclusion of its voluntary pilot program to evaluate the alignment of third-party food safety audit standards with relevant FDA regulations. The […] Read More >>
On June 22, 2023, Bill C-47 received Royal Assent, introducing amendments to the Food and Drugs Act (FDA) concerning Natural Health Products (NHPs). These amendments extend the enforcement power of […] Read More >>
Definition of a Pregnancy Test A urine pregnancy test device is an In-Vitro Diagnostic (IVD) hormonal assay that measures the beta (β) subunit of Human Chorionic Gonadotrophin (hCG) levels in […] Read More >>
On May 12, 2023, Health Canada alerted industry of a new proposal to introduce cost recovery fees for Natural Health Product (NHP) regulatory activities in Canada. The proposal, open for […] Read More >>
The FDA regulation of cosmetic products is designed to protect public health and ensure that consumers have access to safe and accurately labeled cosmetic products. In December 2022, Congress passed […] Read More >>
The Federal Trade Commission (FTC) announced On April 13, 2023, that it has sent notices to approximately 670 companies involved in the marketing of dietary supplements, functional foods, over-the-counter (OTC) […] Read More >>
As of March 21, 2023, the Natural and Non-prescription Health Product Directorate (NNHPD) began applying new refusal criteria against Site Licence (SL) and Foreign Site Reference Number (FSRN) submissions, as […] Read More >>
On March 27, 2023, Health Canada updated the “Policy on Listeria monocytogenes in Ready-to-Eat Foods”. This new policy will come into effect on October 1, 2023. Until then, the 2011 […] Read More >>
This is a reminder to all importers wishing to certify food products under the Voluntary Qualified Importer Program (VQIP) for fiscal year (FY) 2024 that the VQIP Application due date […] Read More >>
The cost of clinical trials is often seen as a prohibiting factor for many companies and organizations with clinical research aspirations. A quick Google search will yield varying results based […] Read More >>
On March 6, 2023, the Food and Drug Administration (FDA) launched a new directory of ingredients used in dietary supplements. The directory will be a “one-stop shop” for ingredient information […] Read More >>
The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. […] Read More >>
Food additives are subjected to premarket review by the FDA, although an exemption applies if a petitioner can demonstrate that an ingredient is Generally Recognized as Safe (GRAS) under its […] Read More >>
On February 22, 2023, the Food and Drug Administration (FDA), released draft guidance regarding the labeling of plant-based milk alternatives. The draft guidance, which provides industry with guidance on labeling […] Read More >>
Back in 2016, the FDA published new requirements for the Nutrition Facts Table (or NFT) on packaged foods. This update was made to reflect new scientific information, linking together diet […] Read More >>
On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>
On December 16, 2022, Health Canada issued a notice to stakeholders regarding their proposal to amend the regulations for Biologic Drugs (Schedule D drugs) in Division 4, Part C, of […] Read More >>
On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR). Health Canada is recommending new provisions for new drug submissions […] Read More >>
Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “new provisions that enable the rolling review of a […] Read More >>
On December 21, 2022, Health Canada opened a consultation on a proposal to amend the labelling of pharmaceutical drugs for human use guidance document. The amendments that have been proposed […] Read More >>