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While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc. in the form of safety...
With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements. The Agencies are considering the industry point of view, too, to simplify the...
Demand for cosmetics is consistently growing, worldwide. All thanks to the online product sale, increased beauty consciousness and younger generation’s lifestyle standards. On the other side, apart from meeting the consumer’s and market demands, there is an increasing responsibility on cosmetic product manufacturers to address the...
Are you a biosimilar/biologic product’s developer/manufacturer? Are you waiting for FDA’s latest stand on biosimilars or soon-to-be Biologics? Here it is. For the development of biosimilars and interchangeable biosimilars, on 11 December 2018, FDA released two new draft Q&A guidance documents under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The agency also proposed...
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way. In brief, Health authorities...
Artificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required. But with the evolution of new generation algorithms and systems, the computational speeds have...
Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices....
With 3,00,000+ Over-the-counter (OTC) products in the USA market alone, it is projected that, so far $105 billion have been saved in doctor visits, diagnostic tests and prescription medications. That makes us wonder, how come they be so cost-effective? Of course, it’s their ability to self-diagnose, self-treat, and self-manage and simple-to-use nature.
The Food, Drug and Cosmetic (FDC...
The global cosmetics production is one of the fastest growing industry globally, with a market size of USD 532.43 billion (in 2017). It is one of the few industries which is not much affected by the ups and downs of the global economic conditions. Even though the overall sale of the products is affected, the industry manages to maintain a steady sales volume. If the market continues to grow...
The advent of internet has fundamentally changed the course of action of almost every industry. Even though internet has been around for a while, it wasn’t until the emergence of Industry 4.0 that the digital transformation started helping the industries to evolve. While industry 4.0 was expected to address the increased need of personalized products with the help of Internet of Things (...
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