COVID-19 Consulting
The COVID-19 pandemic has introduced unprecedented challenges to the medical device and life-sciences industry. From PPE shortages, remote audits, delays in regulatory processes, and much more.
EMMA International has stayed on top of the ever changing quality and regulatory landscape amidst the global public health emergency and has compiled the following resources to keep the life-science industry informated, to ensure life-saving products get to market, and stay on the market.
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COVID-19 Resources
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The National Institute of Occupational Safety and Health (NIOSH) was established in Section 22 of the Occupational Safety and Health Act of 1970. NIOSH began operations in 1971, a year in which the first toxic substances list was published. Since their initiation, NIOSH has grown to not only be a governance body but also a research institute. They are usually at the forefront with other federal departments when human safety is a main risk. Some examples of past human safety risks are the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and most recently the Sars-Cov-2 pandemic.
Every year the FDA compiles its Fiscal Year Report on the State of Pharmaceutical Quality. This report takes a look back at the previous fiscal year and identifies trends throughout CDER and the Office of Pharmaceutical Quality (OPQ) various surveillance activities to assess the state of pharmaceutical quality. Fiscal year 2022’s report card was published last month and provides a great insight into how pharmaceutical manufacturers are navigating a new post-COVID regulatory landscape.
Since the introduction of the term by Seth Frank back in 2000 [1], the idea of digital health has revolutionized many of our current healthcare and global health practices. With roughly 6 billion USD in funding in 2017, the development of digital health technologies and the systems in which they run were appearing at an extremely rapid rate [1,2]. Currently, the FDA categorizes digital health into mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine [2,3].