The FDA has released a new policy titled Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During Public Health Emergency. Within this document, the FDA has declared they do not intend to take action against compounders who prepare alcohol-based sanitization hand rubs as long as the sanitizer is prepared under conditions similar to nonsterile drugs and possess a label consistent with the outlines in the appendences of the FDA document. As well, the formula of the sanitizer must consist of alcohol, glycerol, hydrogen peroxide, and water in the proportions specified in the document as well and cannot contain any other active or inactive ingredient. These rules do not apply to topical antimicrobial drug products nor tentative final monographs for Health-Care Antiseptic Drug Products. The FDA is also encouraging production line companies to attempt retooling in order to begin manufacturing sanitization hand gels. As well, the United States Federal Government declared they would allow manufacturing of hand sanitizers with limited guidance.

Overall, despite these dark and trying times amidst the coronavirus pandemic, there is still hope. Regulatory bodies, such as the FDA, are adjusting their sanitization product regulations to provide an opportunity for many companies to rise to the occasion to help produce and distribute these high in demand sanitization products. Updated regulations, such as allowing retooling and providing guidelines for temporary compounders, make this time easier and the light at the end of this dark tunnel much brighter.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

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Health Canada released a DEL Bulletin, No.74 Disinfectants and Hand Sanitizers, on March 17th with clarifications that followed on March 20th containing details on licensing requirements for disinfectant and sanitization products. Health Canada also released a proactive action plan to increase domestic capacity of these in demand products. The interim regulations will allow disinfectant and sanitization products authorized or registered in the US, MRA or a PIC/S jurisdictions to be imported and sold in Canada to assist with the supply and demand. This will permit these products to be imported and sold in Canada in the interim, even though they do not meet the full Canadian labelling and licensing requirements.

Facilities that currently possess a Drug Establishment License (DEL) or Site License (SL) can begin importing new products once they notify Health Canada of the product, update their import license to include the foreign manufacturer(s)/packager(s)/labeler(s) of the product (which also can be expedited because of this current process), and must maintain the appropriate records on file. Health Canada has also encouraged pre-authorized facilities capable of retooling to begin producing sanitization products.

Health Canada is putting in their best efforts to minimalize the spread of COVID-19 and to assist Canadians with obtaining products to help prevent them from contracting the virus. The release of these new interim regulations to expedite the production and importation of disinfectant and sanitization products is a step towards achieving a future without the virus. Let’s hope the future is soon.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post Health Canada’s Actions to Minimize the Spread of COVID-19 appeared first on Focal Point.

Patent protection is often considered the Holy Grail of innovation. If you have a shiny new invention, it will benefit from long-term protection. A patent can allow you to build your business and hopefully sell it and make you very rich. But like most things, there are shades of grey.

Say you are able to get a patent. How strong is it? Can a smart person work around it? And even if your patent is rock solid, that does not stop copycats. A patent only allows you to sue them for infringement. That’s a huge misunderstanding for many new innovators. What if you launch and five copycats appear on the market? You need deep pockets and a talented legal team to deal with this. I have seen innovators abandon their patents because they didn’t have the funds or stamina for the litigation.

Going back to the entrepreneur with an old molecule. Many of the regulatory hurdles had been overcome by previous innovators. The few remaining ones seemed surmountable. I have seen projects like this become hugely successful with rapid scale up and sales execution. If copycats arrive, the entrepreneurs continued to innovate with product improvements, line extensions, and new sales and distribution channels.

Sure, a rock-solid patent is great to have but it’s not the only option to make you a successful innovator.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Patents” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

The post Patents: Misconceptions and Watch-Outs”. appeared first on Focal Point.

When it comes to complaints, these are things I look at:

1. The seriousness of the complaints. In my world of regulated products, these usually pertain to adverse reactions, issues of health and safety etc.

2. The percent of complaints to units sold.

3. Trends. Are complaints going up, down, sideways?

In the case of my recent sleepless entrepreneur, none of the complaints was particularly serious. In terms of the absolute number, a dozen seemed like a catastrophe. But it turns out that there were over half a million units sold; the complaint rate was about 0.002%, miniscule. In terms of trends, it was a predictable steady growth of complaints as the business expanded. Time for a good night’s sleep!

The other advice I give to entrepreneurs is if you are not getting complaints or at least some type of feedback, I would be concerned. Unless you are an absolute genius, your product will launch with further optimization needed. All within reason of course. So I say, embrace your complaints. Master dealing with them. And use them as learning for your next generation innovation.

Our YouTube Channel showcases our Lectures on Innovation Series featuring our “Complaints” video, which continues this article in more depth. Watch it here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA .

Rob Fichtner, October, 2019

The post How to Handle Complaints Made About Your Innovation appeared first on Focal Point.

Physical Sunscreens vs. Chemical Sunscreens:

According to the American Academy of Dermatology and the American Academy of Dermatology Association, physical sunscreens work like a shield while chemical sunscreens work like a sponge. Physical sunscreens contain the active(s) zinc oxide and/or titanium dioxide, and work by sitting on the skin’s surface deflecting the sun’s rays. On the other hand, most chemical sunscreens contain one or more of the following active ingredients that absorb the sun’s rays: oxybenzone, avobenzone, octisalate, octocrylene, homosalate, octinoxate.

Originally, the chemical sunscreens were used in small quantities for preventing sunburn on vacation. According to a CNN article, the FDA started to become concerned about chemical safety when sun protection agencies started recommending daily application on large parts of the body.

Oxybenzone seems to be the most concerning active ingredient in sunscreens. In a small FDA study of sunscreen chemicals, oxybenzone was absorbed into the body at a concentration of approximately 50 to 100 times higher than the other three chemicals. Other studies have shown a potential link between oxybenzone and changing hormone levels in men, including lower testosterone. According to the article, it is also the most common cause of contact allergies and can also leach into breast milk.

Experts say that you should NOT stop using sunscreens. Further studies need to be conducted to determine the medical implications, if any, of sunscreen absorption. However, the increasing awareness surrounding the potentially harmful absorption of these chemicals encourages consumers to be more cautious about the type of sunscreens they purchase. Alternative sun protection methods include avoiding sun exposure at peak times, using protective clothing, and wearing a hat.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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