by Katrina Rogers | Jan 1, 2019 | Uncategorized
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...
by Katrina Rogers | Dec 30, 2018 | Uncategorized
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...
by Katrina Rogers | Dec 27, 2018 | Uncategorized
– 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...
by Katrina Rogers | Dec 25, 2018 | Uncategorized
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
by Katrina Rogers | Dec 23, 2018 | Uncategorized
In late November the FDA released two draft guidance documents addressing manufacturer applications for Clinical Laboratory Improvement Amendments (CLIA) waivers for the in vitro diagnostic (IVD) devices. These draft guidance documents propose updates to the 2008 CLIA...
Recent Comments