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Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
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Drug development is an extremely complicated process, both from a technological perspective and a regulatory one. ...
Last week the FDA announced it is establishing a digital health advisory committee to increase its understanding ...
This week the FDA revised its guidance for magnetic resonance (MR) devices. In this blog we will explore the ...
In this blog, we will explore how AI/ML is revolutionizing the medical device industry and the FDA's plans for ...
In this blog we will go over the high-level details of what to expect when you’re inspected by the FDA.
The medical device industry is a dynamic and ever-evolving sector that plays a pivotal role in the healthcare ...
This year’s ASTRO Annual Meeting was another great opportunity to learn from industry leaders in radiation ...
In this blog, we will delve into the regulatory framework governing radiopharmaceuticals, highlighting the key ...
In honor of this month being Cybersecurity Awareness Month, this blog will delve into all of the regulatory ...
In this blog, we will delve into the world of CAPAs in the life sciences industry, exploring their significance, ...
Theranostics are innovative, and beneficial to patients in that they find the cancer cells and also deliver ...
Last week, the FDA announced a new proposed rule that seeks to amend its regulations specifically around LDTs. ...
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