Katrina’s Blog™

I was reminded this month that the FDA is the regulatory body for a wide variety of radiation-emitting products available in the U.S. when I received this notice of the final guidance "Classification and Requirements for Laser Illuminated Projectors”. That’s right,...

Why Isn’t this Obvious?I participated in a commercial webinar last week about improving clinical trial data acquisition, patient participation, and treatment compliance using mobile applications with a thoughtfully designed user experience (UX). The presenters...

In a previous post I discussed the FDA’s Framework for Real World Evidence program. The latest update to this program is a draft guidance intended to encourage sponsors submitting INDs, NDAs, and BLAs that use Real World Evidence (RWE) to support a regulatory decision...

Patient Preference Information (PPI) is one type of patient feedback that provides assessments of the desirability or acceptability of different treatment alternatives. This information shows the value attributed to different aspects of each alternative and it can be...

Draft guidance was issued in March on the development and submission of near infrared (NIR) analytical procedures for use during the manufacture and analysis of pharmaceuticals. NIR is a spectroscopic technique that uses wavelengths of light just below the visible...