Katrina’s Blog™

At first glance, one might think that copying an innovator drug to produce a generic drug would be pretty simple. Most of the development work has already been done, and the generics producer only has to copy that information and receive approval for an Abbreviated...

The FDA released the code and technical documentation for their MyStudies Platform last November and hosted a full day of webinars in early May to orient developers on the system. All the webinars and complete documentation for the system may be found at this SBIA web...

Digital Health Software Precertification (Pre-Cert) Program – part 3On May 22 the FDA posted a call for test cases to participate in the 2019 Digital Health Software Precertification (Pre-Cert) Program Test Plan (see my previous post here). They are looking for...

As business leaders, scientists, and entrepreneurs, we are often looking for data to help us make a business case, understand social situations, and scope the feasibility of a new idea. The U.S. government collects a wide range of data through the Census Bureau that...

In a previous post, I discussed guidance on how the FDA intends to use consensus standards to facilitate review of device submissions. Consensus help device manufacturers simplify their submissions using documented evidence that their devices conform to those...