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!
The Drug Development Tool Qualification Programs
The FDA has established 3 programs for qualification of Drug Development Tools (DDT): Animal Models, Clinical Outcome Assessments, and Biomarkers A qualified DDT is publicly available to be used in any drug development program for its qualified context of use, and...
Electronic Regulatory Submissions Part 5
The Common Technical Document Provides a Structure for Submission (Note: This post is part of a multi-part series on the CTD this fall) Before it became electronic, the common technical document (or CTD) was proposed by an ICH steering committee as a means to...
Webinar on Classifying Your Device
On November 5th, CDRH will host an Industry Basics Workshop on 513(g) request for information regarding the classification of a medical device. The session will be immediately followed by another on exemptions for custom devices to address unique patient or physician...
Electronic Regulatory Submissions Part 4
Stay Current on Guidance When Planning Your Submissions (Note: This post is part of a multi-part series on the CTD this fall) In my last post in the series we reviewed what we could find on the history of a main eCTD guidance. There are a fair number of eCTD related...
Guidance on Clinical Bioanalysis
Q&A on Evaluating Internal Standard Response In September, the CDER issued a level 2 guidance containing a series of questions and answers on the evaluation of internal standard responses during bioanalysis of clinical trial samples. Normally used in...