Michael Causey
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.
Almost across the...
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and...
Michael Causey
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based...
Alexandra Brown
My husband and I both like to run. I run about three miles once or twice a week—if the weather’s not too bad, and if I don’t have something else going on. Keith, on the other hand, runs half...
Jeff Mazik
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year,...
Margaret A. Hamburg
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens...
Gary Minks
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be...
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and...
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying...
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a...
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,...
The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations...
Quality Digest
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the...
Alexandra Brown
The past five to 10 years, hospitals and physician offices have been in a mad dash to implement electronic health records (EHRs) to meet governmental regulatory requirements. Now that most projects...
Katherine Watts
Healthcare in 2014 is in a state of flux. The Affordable Care Act (ACA) health insurance exchange marketplace opened in October of 2013 with a rough start, and it has still not gained traction...
Barry Plunkett
Leadership at healthcare organizations is being tested like never before. The move away from a fee-for-service model to a patient-outcome-based model means management has to get clinical-care teams...
Michael Causey
Well, boys and girls, Halloween is approaching. Although it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux-scaring folks, the FDA is acting like a responsible parent by...
The QA Pharm
Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.
Go figure.
This...
Tamar June
The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will...
Alexandra Brown
As a physician, I enjoy listening to nonphysicians tell me how to motivate doctors. I don’t mean this in a totally snarky way (well, maybe just a little). These conversations often highlight the...
