FDA Features

Michael Causey's picture
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of...
Michael Causey's picture
Michael Causey
The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look....
Tripp Babbitt's picture
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...
Melinda Plaisier's picture
Melinda Plaisier
  We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a...
Michael Causey's picture
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...
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...
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...
Michael Causey's picture
Michael Causey
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks. FDA’s Philadelphia office hit...
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...
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...
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...
Tamar June's picture
Tamar June
In a previous column, Michael Causey looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary...
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...
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...
Michael Causey's picture
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA. As the agency...
The QA Pharm's picture
The QA Pharm
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the...
Russ King's picture
Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and...
Howard Sklamberg's picture
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of...