Healthcare Features

Jeff Mazik's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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's picture
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...
Russ King's picture
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges...
Whitney Andrews's picture
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to...
Thomas Prewitt Jr.'s picture
Thomas Prewitt Jr.
I am concerned about the rush to consolidation we are seeing in the hospital industry. It seems all too tidy and easy, and if there is anything I have learned from my 30+ years in clinical medicine...
Taha A. Kass-Hout's picture
Taha A. Kass-Hout
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used...