Katrina’s Blog™

 - for QC of Protein DrugsMass spectrometry has been a critical tool for drug discovery and development since the advent of atmospheric pressure ionization sources (ESI and APCI) in the 1980s. As a mass spectrometry expert, I have been looking forward to the move...

Part of the work in modernizing the 510(k) device approval pathway, first established by congressional amendment of the FD&C Act in 1976 and updated in subsequent amendments, is an examination of how comparison of new devices to older (predicate) devices promotes...

Is the First Genetic Variants Database to be Recognized by the FDAOn December 4, 2018, the FDA announced recognition of the ClinGen Clinical Genome Resource as a resource for clinicians and developers of genetic tests. This database is the first genetic variants...

MDUFA Small Business Qualification and Certification for a Business Headquartered in the United StatesQualifying as a small business with the FDA gives a company a substantial discount in the user fees required under the Medical Device User Fee Amendments (MDUFA)....

– Approvals Occurred Between 21DEC2017 and 18SEP2018Each year the FDA publishes data on the devices receiving approval through the various submission pathways. References to much of this information are available in several locations including the Federal Register. In...