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!
What is a Drug Master File (DMF)?
A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type...
Streamlined Process for Investigational In Vitro Devices
Codeveloped with Oncology Drugs The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process...
Is Your Automated Electronic Defibrillator (AED) FDA Approved?
In 2015, the FDA published a final order establishing that all Automated Electronic Defibrillators (AEDs) and their accessories require pre-market approval (PMA) based on the adverse event report and product recall history of these devices. AEDs without PMA will no...
Bioanalytical Methods Templates for Your NDA/BLA
As we learned in the eCTD series of posts, the implementation of the standard by the FDA includes a series of technical specifications which define the format of an application and its sections. The latest technical specification, Bioanalytical Methods Templates,...
Happy Holidays, Everyone!
I'll take a brief break from posting new material on December 24th and 26th. Please browse some earlier posts and have a happy holiday!Reach out to me if you want to know more or discuss your medical product development...