This week we’ll be attending Life Science Innovation Northwest (LSINW), a virtual two-day meeting of investors, public and private life science organizations, research institutions, scientists, entrepreneurs devoted to the life science ecosystem in the upper left...
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Katrina’s Leadership Reading List for 2021
2020 has been a tough year in many ways, but we’ve also seen multiple opportunities for constructive change. Working from home and other flexible arrangements are here to stay. Widespread compliance with stay-at-home orders has shown us we can change atmospheric...
I’m Excited by This Year’s Nobel Laureates in Science & Medicine
The winners of the Nobel Prizes are announced in October each year, and this year’s science Prizes represent significant advances in our knowledge. I’m super excited by this year’s Nobel prize in Chemistry, given to Jennifer Doudna and Maxine Charpentier for their...
FDA Sponsors Innovation in Sterilization Technologies
Regular readers will recall my post earlier this year on the shutdown of a Sterigenics plant in Illinois using ethylene oxide to sterilize medical devices due to repeat environmental emissions of the sterilant, which is known to cause cancer. The shutdown continues...
The Compliance Program Guidance Manual Guides Inspections
Similar to the MAPP discussed in a previous post, the Compliance Program Guidance Manual (CPGM) contains the instructions used by FDA personnel to perform the agency’s compliance work. Unlike the MAPP, the instructions in the CPGM are more like FDA guidance in that...
Is Your Automated Electronic Defibrillator (AED) FDA Approved?
In 2015, the FDA published a final order establishing that all Automated Electronic Defibrillators (AEDs) and their accessories require pre-market approval (PMA) based on the adverse event report and product recall history of these devices. AEDs without PMA will no...
Bioanalytical Methods Templates for Your NDA/BLA
As we learned in the eCTD series of posts, the implementation of the standard by the FDA includes a series of technical specifications which define the format of an application and its sections. The latest technical specification, Bioanalytical Methods Templates,...
Happy Holidays, Everyone!
I'll take a brief break from posting new material on December 24th and 26th. Please browse some earlier posts and have a happy holiday!Reach out to me if you want to know more or discuss your medical product development...