FDA Features

Jim Frost's picture
Jim Frost
This flu season has been worse than normal. The Centers for Disease Control and Prevention (CDC) data show that the flu has struck early and hard. Influenza cases shot up during December rather...
Tamar June's picture
Tamar June
A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic...
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FDA
Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug...
Patrick Stone's picture
Patrick Stone
It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health? The recent...
Margaret A. Hamburg's picture
Margaret A. Hamburg
Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting...
Susan Kelly's picture
Susan Kelly
I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA...
Patrick Stone's picture
Patrick Stone
Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’...
Patrick Stone's picture
Patrick Stone
During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were four years previously. It worked for Reagan, so we’re going to try a...
Michael Causey's picture
Michael Causey
The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more...
Michael Causey's picture
Michael Causey
Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the...
Alberto Gutierrez's picture
Alberto Gutierrez
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k...
Michael Causey's picture
Michael Causey
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own...
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Banner Medical
Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry. The company believes this...
Michael Causey's picture
Michael Causey
Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier...
Michael Causey's picture
Michael Causey
Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the...
Julie Gunlock's picture
Julie Gunlock
This year will mark another push for aggressive food regulation at the Food and Drug Administration (FDA). On tap, salt regulations and industrywide regulations dictating which foods can be...
Michael Causey's picture
Michael Causey
It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (FDA) overplaying its regulatory hand. We’re not...
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ASQ
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of...
Michael Causey's picture
Michael Causey
Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it...
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FDA
The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States...