Clinical trials proceed with four phases to assess the safety and efficacy of an Investigational Product (IP) [1]. The sample size should be considered with extra care for each of […] Read More >>
The Canadian Food Inspection Agency (CFIA) announced on October 30, 2020, that it would update its Compliance and Enforcement Policy, which would come into effect on November 1, 2020. The […] Read More >>
The dates for renewal are now open. The Food and Drug Administration (FDA) requires that all businesses that manufacture, process, pack, or store food, beverages, or dietary supplements for sale […] Read More >>
Labelling of packaged food in Canada has undergone some regulatory changes in the last few years, and there are some proposals for label revisions that have been active for some […] Read More >>
In Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to […] Read More >>
Recruitment is a crucial part of the Clinical Study workload. Even if no clinical trial is actively searching for subjects, recruitment is an ongoing process in order to build a […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] Read More >>
The temporary exemptions for the importation of hand sanitizers, which was announced March 27, 2020, as part of the Natural and Non-Prescription Health Products Directory (NNHPD)’s interim measures have now […] Read More >>
In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by […] Read More >>
A “Brand Name” is defined as the name under which your NHP (Natural Health Product) is registered or sold. Selecting a “Brand Name” for your NHP is an important part […] Read More >>
On July 15, 2020, the next scheduled compliance date for the Safe Food for Canadians Act & Regulations came into effect for businesses in the manufactured food sector. The compliance […] Read More >>
In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows […] Read More >>
In response to the COVID-19 pandemic, Health Canada implemented in March and April 2020 interim measures aimed to facilitate the importation of products that can help to limit the spread […] Read More >>
Consider this hypothetical situation: you’ve got this great food product, maybe it’s one of the best on the market, or perhaps it’s a one of a kind with no real […] Read More >>
The Safe Food for Canadians Act & Regulations came into force on January 15, 2019, and had outlined compliance dates in 2020 and 2021 based on the type of food […] Read More >>
To facilitate the distribution of food during the COVID-19 pandemic, the US FDA recently issued a guidance document titled “Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health [&hell Read More >>
The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in […] Read More >>
Health Canada has recently released an Interim Order (IO) for the importation and sale of Class-IV medical devices used to diagnose, treat, or prevent COVID-19. **note: An interim order is […] Read More >>
Recent news about an employee testing positive for COVID-19 has prompted the Canadian Federal Inspection Agency (CFIA) to release update guidance about preventing and responding to COVID-19 in meat slaughter […] Read More >>
On April 1, the Ontario Government announced a $50 million fund called “The Ontario Together Fund” which is intended to help businesses produce essential medical products amid the COVID-19 pandemic. […] Read More >>
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