FDA Features

Bakul Patel's picture
Bakul Patel
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It...
Margaret A. Hamburg's picture
Margaret A. Hamburg
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh...
The QA Pharm's picture
The QA Pharm
Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance...
David S. Buckles's picture
David S. Buckles
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center...
Michael Causey's picture
Michael Causey
In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex...
Kimberly Egan's picture
Kimberly Egan
What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you are eating contains any genetically modified organisms,...
Michael Causey's picture
Michael Causey
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices...
John Roth's picture
John Roth
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to...
Michael Causey's picture
Michael Causey
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been...
James Andrews's picture
James Andrews
T ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and...
Michael Causey's picture
Michael Causey
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the...
Quality Digest's picture
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics,...
Michael Causey's picture
Michael Causey
The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great...
Margaret A. Hamburg's picture
Margaret A. Hamburg
The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I...
Anonymous's picture
Christy L. Foreman
A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having a heart attack—is in my opinion an extremely smart...
Michael Causey's picture
Michael Causey
A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause. “It’...
Kimberly Egan's picture
Kimberly Egan
Nutrition labels have been much in the news lately, presumably because we have once again won the fattest nation contest. The Food and Drug Administration (FDA) and various nutrition researchers...
Michael Causey's picture
Michael Causey
Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they...
IntraStage's picture
IntraStage
The first production Model T auto in 1908 ushered in a new era of transportation by shrinking dramatically the time it took for people to move from place to place. Like the Model T, communication...
Kimberly Egan's picture
Kimberly Egan
On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing...