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!
Wishing you a Peaceful and Prosperous New Year
I have many interesting topics and ideas to share with you in 2019, including new ways to look at device approvals, some new reading lists, and posts on topics as varied as data integrity, clinical trials design, and medical software apps. Have a wonderful new...
Consulting with FDA on Use of Novel Surrogate Endpoints
In a recent issue of SBIA Chronicles, the agency is encouraging sponsors to request type C meetings early in the development process when they plan to use novel surrogate endpoints (SE) as primary measures of efficacy in trials for a new drug. These SE are biomarkers...
Involvement of Payors in Pre-Submission Discussions
– For New Medical DevicesPatients whose insurance policies don’t cover innovative new treatments are often excluded from treatments that could be beneficial because they can’t afford them. The FDA is working on approaches to minimize the delay between approval and...
Merry Christmas and Happy New Year
I'd like to wish for all my readers to have the merriest holiday and a peaceful and prosperous new year. I'll have a new post for you after Christmas. Text Copyright © 2018 Katrina Rogers
Draft Guidance on CLIA Waivers
In late November the FDA released two draft guidance documents addressing manufacturer applications for Clinical Laboratory Improvement Amendments (CLIA) waivers for the in vitro diagnostic (IVD) devices. These draft guidance documents propose updates to the 2008 CLIA...