Public health concerns regarding vaping products Every year, more than 8 million people die from smoking-related illnesses, including 1.3 million non-smokers exposed to second-hand smoke. (Source: WHO 2023.) With the evolution of vaping products, including pharmaceutical nicotine vapes, cannabis vapes, and non-therapeutic vapes, people are curious to know if nicotine addictions and smoking-related health harms…
The ethos that high-risk activities should elicit the most significant mitigation effort, and low-risk, lower effort has been a mainstay of the global regulatory approach to risk management of therapeutic products for many years. In 2006, ICH Q9 Quality Risk Management was published and included the statement: The level of effort, formality and documentation of…
In an era where health and well-being are paramount, the pharmaceutical industry plays a pivotal role in ensuring the safety of consumers. However, the reality is that pharmaceutical TGA recalls can and do occur, posing challenges to sponsors. In this Blog, we shed light on how PharmOut can provide support and expertise preventing these critical…
New FDA regulations for cosmetic products: Updates to the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 USC 364 (FDA Cosmetic Regulations). MoCRA: FDA cosmetic manufacturing regulations MoCRA: Effective date for FDA Cosmetic Regulations Most of the provisions in MoCRA take effect at the close of 2023. These include mandatory facility…
It might seem that changes to pharmaceutical regulations move at a glacial speed but, be assured, that they do move and they are happening. Back in August 2020 (you remember that year – you made a LOT of sourdough), Australia’s Therapeutic Goods Administration (the TGA) announced a consultation regarding amendments to the Poisons Standard. Amongst…
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