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!
Physiologically Based Pharmacokinetic Modeling
In Drug Development CDER published a survey article in February 2019 giving a capsule description of the application of Physiologically Based Pharmacokinetic Modeling (PBPM) in modern drug development. The article presents one of the nicest visuals for PBPM I’ve seen...
Clinical Immunogenicity Testing of Therapeutic Proteins
Guidance for Development of Anti-Drug Antibody TestsA fairly common event with therapeutic proteins is the generation of immune responses to the therapy or related proteins by the patient’s immune system. These immune responses have the potential to affect product...
Scott Gottlieb Stepping Down as Head of the FDA
The announcement on March 5th (in a staff letter which was shared on Twitter) that Scott Gottlieb, Commissioner of the FDA, would resign at the end of the month has created considerable speculation in the press. Along with questions about why (Dr. Gottlieb gave family...
Devices Exempted from Premarket Notification Requirements
Not all class I or II medical devices are required to undergo a premarket notification process with the FDA. Additionally, certain preamendment unclassified devices are considered to be sufficiently well understood that they, too, do not require premarket...
What Are All These Device Review and Approval Pathways? Part 8
Humanitarian Device ExemptionA rare disease is defined in the Orphan Drug Act (ODA) of 1984 as a disease or condition that affects fewer than 200,000 people in the United. Because so few patients are affected, it can be difficult to gather enough clinical evidence for...