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Keeping Up With Mobile App Innovations
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 phone. That is just one example of how mobile medical applications are transforming healthcare. As…
Raise a Glass to a Dumb Medical Device Tax Brewed in D.C.
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’s great to be here with you tonight. I love this great state of [fill in the blank]. Erica and I…
Simple Nutrition Facts for Complicated People
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 have all put out some thought-provoking information for us to ponder. The problems First, people don’t…
Study: FDA Enforcement Growing for Medical Device Companies
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 were being talked about were probably right. Maybe some in the medical device industry can be forgiven…
Speeding Time to Market at Motorola
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 technologies such as email, mobile phones, and the Internet are dramatically shrinking the time for…
Save Us from Sprouts and Cilantro
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 everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,…
How Effective Are Flu Shots?
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 than the more usual January or February, and 47 states report widespread influenza cases. I get a flu…
FDA Warns WebTrader Users: Remove Your Files or Lose Them
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 regulatory submissions, warns those using the WebTrader for electronic submissions to delete their…
A New Era in Food Safety Oversight
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 Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The suspension…
It’s Time for the FDA and States to Step Forward for Public Health
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 news is troubling. For example, a shipment of tainted steroid from a Massachusetts-based compounding…
Global Cooperation Helps Expand Safety Net
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 task. It was heartening for me to sign two cooperative arrangements with some of our international…
Regulatory Science Is Not Boring
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 consumer updates, which are news stories posted on www.fda.gov designed to give consumers important…
Give the FDA More Authority Over Compounding Pharmacies
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’t distribute outside their home state (no interstate sales). This means that compounding pharmacies…
Is the FDA Better Off Than It Was Five Years Ago?
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 variation of it here. Is the Food and Drug administration (FDA) better off than it was four or five…
What the Heck’s Going On at the FDA?
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 George Smiley and John le Carré types than we’d ever imagined. According to reports in The New York…
FDA and EU Spar on Medical Device Regulation
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 European Union. They apparently aren’t happy that the Food and Drug Administration (FDA) is writing…
FDA Introduces Triage Pilot Program
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), sooner than expected. This will be due to a six-month pilot program called Triage, launched…
Medical Device CEO Laments ‘Anti-Industry’ FDA Culture
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 agenda” over dissenting science or how its own advisory boards vote on medical device classification is…
Going Long in Medical Device Manufacturing
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 investment achieves multiple payoffs—in relationship-building with customers, in risk mitigation, and in…
Lawmakers’ Silly Season No Laughing Matter for Device Industry
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 regulation in 2012, and that will only increase if President Obama is reelected in November. The…
FDA Budget Could Hike User Fees, Overseas Inspections
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 United States Government, Fiscal Year 2013. While it is one of the few agencies that could see its overall…
Misguided FDA Food Regulations Will Hike Costs, Not Safety
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 advertised on television. In October 2011, the FDA announced in the Federal Register that it would begin…
FDA Offers Salty Recipe for Increased Food Regulation
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 going to settle this controversy here, but some experts suggest you may be able to sprinkle a little…
Quality Pro Salaries Keep Pace with Inflation
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 quality and its positive impact on an organization. The survey results also show that experience…
FDA Reorganization Signals More Inspections for Drug, Device Firms
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 was scripted by the same team handling Steve Carell’s departure from The Office and the ushering in…

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