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 the Division of Applied Regulatory Science?
and what do they do?Part of the Office of Clinical Pharmacology, the Division of Applied Regulatory Science (DARS) performs applied research to “develop and evaluate novel tools, standards, and approaches to assess the safety, efficacy, quality, and performance of...
Question-based Review Process Improves ANDA Submission and Review
Following the release of the report “Final Report on Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach” in 2003, the Office of Generic Drugs (OGD) recognized that its process for review of ANDAs needed an update to meet the new risk-based approach and...
Webinar on Quality Systems Basics for Device Manufacture
The Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) will be hosting a workshop for medical device manufacturers on November 6, 2018. The workshop, which has a webinar format, will focus on 2 parts of the...
What is the Quality in 501(k) (“QUIK”) Review Program Pilot?
CDRH is currently running a pilot program to accept 510(k) premarket notification submissions packaged using the eSubmitter tool (see my previous post). The purpose of the pilot is to collect information to assess the value of the template in facilitating review and...
Collaborative Communities Initiative for Medical Devices
One of the current strategic priorities for CDRH is the creation of Collaborative Communities to allow interested stakeholders (both private and public, including the FDA) to work together medical device challenges. These communities may be convened by any...