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...
Uncategorized
Mining U.S. Census Data for your Business
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...
The Device Standards and Conformity Assessment Program
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...
New CDER FDA-TRACK web page
In late May CDER launched a new web page for their portion of FDA-TRACK, the performance management system used by the FDA to monitor the agencies’ programs. The new web page provides business intelligence and analytics for the division using 7 dashboards:Policy and...
LSW East/West Summit focused on Neuroscience in the Northwest
It was a thought-provoking day last Thursday at the Life Science Washington East/West Life Science Summit. After hearing Amy Bernard’s call for collaboration with the Allen Institute for Brain Science, we participated in a discussion of neuroscience innovation at...
Join Us Today at the LSW East/West Summit
Readers in an around Spokane today should consider joining us to learn more about neuroscience research and development in Eastern Washington at the Life Science Washington East/West Life Science Summit. The conference started with a networking event last night and...
Draft Guidance on Pediatric Nonclinical Safety Testing
Last September the International Council for Harmonization (ICH) released its draft guideline "Nonclinical Safety Testing in Support of Development of Paediatric Medicines – S11” to provide direction on safety studies required to support the development of pediatric...
Ebook “Process Improvement Using Data”
Practitioners of quality rely on data to determine root causes and devise effective solutions and process improvements. There are many resources available on the subject, but few are free, and rarely do we find a free resource that is as clear, usable, and...