THE LATEST FROM FOCAL POINT RESEARCH
13Dec

Pharmacovigilance: Safety in Drugs

Pharmacovigilance: Safety in Drugs

What is Pharmacovigilance? Pharmacovigilance is defined by the World Health Organization as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. In simpler terms, pharmacovigilance can be defined modestly in two words, drug safety. The study of drugs and their associated risks and effects does not simply end after lengthy studies and clinical trials.  Long after their development phase it is important that their ongoing effects and interactions with consumers continue to be monitored. What is the importance of Pharmacovigilance and what are its effects? A necessary step for not only prescription drugs but those less heavily regulated like OTC drugs, pharmacovigilance helps to monitor the safety of these products after consumer consumption. Recently, it has been seen that the FDA is choosing to crackdown on the safety of certain medications.  It was reported by USA Today that the FDA had begun an intensive investigation into certain blood pressure medicines with suspicions of contamination by cancer-causing impurities. These further investigations are essential to ensure the safety of consumers. With recall of medications that exhibit serious side effects or signs of contamination, the health and safety of [...]

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In with the New Out with the Old: Acne Therapy and other Monographs Under Review

In with the New Out with the Old: Acne Therapy and other Monographs Under Review

When developing a product that requires market authorization, either by way of a DIN (drug identification number) or an NPN (natural product number), product monographs are essential documents provided by Health Canada that layout mandatory label information. These monographs outline key details for products such as the acceptable qualifications for a product to be recognized as a drug product or natural health product based on their active ingredients, labelling requirements for these products, and other information.  There are a few monographs that are currently under periodic review with Health Canada and have also recently gone through consultation periods with the public to determine if these proposed revisions will work for the private sector. These monographs include Anti-Dandruff, Medicated Skin Care, and Acne Therapy.  Many of the proposed changes to these monographs are set to potentially change the allowable claims for these products and other key labelling requirements. In particular, there could potentially be several changes to the Acne Therapy monograph that could impact products under this category: Statements to the Effect of… “Statements to the effect of” has been proposed to be eliminated with the new electronic form submission. The revised monograph could veer off the [...]

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Left Out in the Cold: CBD as a Drug alongside Recreational Cannabis Legalization

Left Out in the Cold: CBD as a Drug alongside Recreational Cannabis Legalization

The cousin of the cannabinoid family that sits alone in the corner, cannabidiol (CBD) is a relatively silent member in the recreational cannabis legalization family. The non-psychoactive counterpart to THC, this compound had a much lower profile until recently. Before the recent Canadian federal legalization of recreational cannabis, there were high hopes that CBD would present a wealth of economic growth and business opportunity. However, this proved to be quite the disappointment to the business community. In a surprising move made by Health Canada, CBD has been added to the prescription drug list rather than being classified as an NHP (natural health product). CBD has long been associated as treatment for a variety of ailments and a quick internet search for the benefits and use returns treatment for ailments such as depression, anxiety and even seizures. An NHP is not allowed to make claims to treat more serious diseases and conditions like these. It’s for these reasons that CBD was left at the platform while recreational cannabis has left legalization station. NHPs are considered as a form of self-care without the requirement of intervention by a medical practitioner. However, the diseases that CBD aims to treat are much [...]

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FDA proposes 40-year-old allergen survey to Gather Consumer Information

FDA proposes 40-year-old allergen survey to Gather Consumer Information

Anywhere you go its hard to not come across some form of cosmetic product. Imagine yourself as a consumer looking to purchase a tube of red lipstick.  There are more than a dozen brands capable of providing you with a vast selection for such a simple request.  With a flooded market comes time to get down into fine details. It comes as no surprise that now more than ever consumers are likely to look for certain ingredients or absence of some to select the product they are going to purchase. From fears of sensitivity to sub-par performance, there are many reasons why some consumers choose one product over another. For brands to remain at the height of competition they often advertise the absence of ingredients to stand-out from the competition.  Once an ingredient has a bad reputation it is hard for it to crawl its way back up the tunnel of despair and back into the light of positivity. A true example of a hive mentality, once an idea is thrust into the limelight it is often adapted to the whole of consumer consciousness. The FDA has proposed a new allergen survey for cosmetics which will in turn help the [...]

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Innovation meets Beauty Savvy: 5 Cosmetic Trends to Watch

Innovation meets Beauty Savvy: 5 Cosmetic Trends to Watch

1. Cannabis Usage Trends

With growing global leniency on this once highly regulated and stigmatized substance, a change in perspective is having a profound effect on its use in cosmetics and other forms of personal care. Big companies like Estee Lauder are starting to cash in on cannabis ingredient trends. As part of their brand Origins, they will be releasing a calming face mask with the inclusion of cannabis sativa seed oil. The first Estee Lauder Company owned product to be released with cannabis-based ingredients, it comes as no surprise that in a time of social change that brands will capitalize on the beneficial aspects of this once controversial ingredient. More than smoke and mirrors, cannabis derivatives like CBD have been shown to provide valuable benefits for skin care.

2. Use of Nutraceuticals and Nutricosmetics

Now more than ever, health is becoming an ever-growing concern. Nutricosmetics, a definition not recognized by the FDA or Health Canada includes natural products with the goal of the promotion of healthy hair and skin. The concept of beauty from within is an ever-growing phenomenon. Far from a new concept, trends in supplements [...]
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