New HHRA Guidance in BC
The British Columbia Ministry of Health recently issued its first version of the Guidance for Prospective Human Health Risk Assessment. The document is available for comment for one year, after which it will be updated to reflect current regulations and policy, and incorporate appropriate feedback. After that time, BC MOH notes that the guidance document …
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Nitrosamine Impurities – Clearing up the Obscurities
Nitrosamine Impurities – The Basics Nitrosamines (also referred to as N-nitrosamines) are compounds that contain a nitroso group bonded to an amine group. They are typically formed through a condensation reaction between an amine and nitrous acid. We have known about the existence of nitrosamine impurities for quite some time as they are commonly found …
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Study Monitoring During A Pandemic – What You Need To Know About Virtual And On-Site Monitoring Of Nonclinical Studies
COVID-19 has had an unmeasurable toll on us both personally and professionally. It has affected every aspect of our lives, including the monitoring of nonclinical studies. Arguably, monitoring has been impacted more than most other aspects of drug development. While restrictions have loosened during the pandemic, working in tightly regulated environments such as nonclinical CROs …
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Radon
Radon is a radioactive gas that is found naturally in rocks, soil and water. Radon is formed by the natural breakdown of uranium in soil and rocks. Radon gas moves through the ground and can enter a home through cracks in floors, walls and the foundation. Radon levels will vary from one house to another, …
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Lead in Drinking Water
The level of public concern related to lead in drinking water is high, due to the reports of community exposures reported in the media in recent years. While the various governmental organizations in Canada and the US have lead-management strategies in place, the situation is complex. Why is lead present in drinking water? Lead is present …
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Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me?
Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me? What are PFAS? Perfluoroalkyl substances (PFAS) represent a group of man-made fluorinated organic compounds that are highly stable and persistent in the environment. These compounds have been used in industrial applications and consumer products since the 1950s, and many different PFAS have …
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Planning to File Your 505(b)(2) Product in Canada?
Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size …
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FDA’s eCTD Mandate: Are You Ready?
When FDA posted their eCTD mandate last year, it was more of a whisper than a bang. It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later. The deadlines are quite clear: After May 5, 2017 The following submission types must …
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