Katrina’s Blog™

On June 3rd the FDAs Oncology Center for Excellence announced the launch of a new call center known as Project Facilitate to increase access to unapproved oncology therapies for use in patients who are not eligible for the clinical trial(s) for those therapies....

Expediting Development of Oncology TherapeuticsConferees at the American Association of Cancer Research in March had the chance to hear about master clinical trial protocols from Marc Theoret, who is the Lead Medical Officer in the Office of Oncology Drug Products at...

Dear Readers:As summer starts, I’ll be reducing the frequency of my posts to give me a bit of extra time for some fun. Look for my updates twice a week (on Tuesdays and Thursdays) and be sure to contact me if you have a topic you’d like me to look into.Katrina

Regular readers will recall my previous post on framework for Real World Data (RWD)/Real World Evidence (RWE) and its potential role(s) in drug approvals. Patient-Reported Outcomes Measures (PROM) can fill a similar role in medical device submissions. A PROM is a...

The FDA’s Pre-Submission (Pre-Sub) program allows sponsors to request feedback from the agency on their planned medical device submissions. The original Pre-Sub guidance (issued in 2014 and updated in 2017) described 6 specific mechanisms for...