Katrina’s Blog™
Insightful News and Commentary
On leadership, product innovation, talent cultivation, and ecosystem development across drugs, devices, diagnostics, and digital health tools.
Join us as we explore the latest trends and share expert insights to help you navigate the ever-evolving landscape of healthcare innovation.
Let’s embark on this journey of transformation together!
Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)
Chapter 6 – Biomedical Mobilization Against COVID-19 The response of our biomedical community to the novel coronavirus outbreak has been impressive, and is illustrated in this slide from a JP Morgan webcast on COVID-19 and the Markets held on March 20th...
Standards Organizations Play a Role in Medical Product Regulation
Regulatory bodies worldwide make use of consensus standards developed by independent organizations to establish best practices and conceptual harmony on specialized areas of expertise. Standards organizations for drugs include the regional Pharmacopeia USP, EP, and JP...
What are the Pharmacopoeia?
Traditionally, pharmacopoeia is a book of medicinal drugs with their effects and directions for use. Today, the pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health. Part of that mission includes maintaining a...
Using Inspection Procedures & Guides as a Preparation Tool for Medical Device Inspection
If you are involved in the development or manufacturing of a medical product, sooner or later, you will face a regulatory inspection. The individual regulatory agencies publish many of their inspection procedures online, and these documents are valuable references for...
Three-Tiered Approach to Regulation of Next Generation Sequencing
With the recent approval of three new next generation sequencing diagnostic tests for tumor profiling, CDRH also announced their approach to regulating such tests. There are three levels of validated biomarkers addressed in each of the market authorizations for the...