Inside FDA Compliance

Michael Causey’s picture

By: 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 diverted from its proper use at the United States Patent Office (USPTO).

Critics argue that, as a self-funded agency, USPTO should not be impacted by the “sequester” game of chicken both sides of the aisle are playing.

Michael Causey’s picture

By: 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 pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number of areas.

Quality Digest’s picture

By: 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, Box was certainly very well known by those who have studied or practiced industrial statistics.

Michael Causey’s picture

By: 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 in a forest isn’t always so great elsewhere.

Margaret A. Hamburg’s picture

By: 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 speak for everyone at the FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones.

Christy L. Foreman’s default image

By: 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 phone. That is just one example of how mobile medical applications are transforming healthcare.

Michael Causey’s picture

By: 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 miss being here, especially when we’re stuck in that snake pit called Washington, D.C.”

Kimberly Egan’s picture

By: 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.

Kimberly Egan’s picture

By: 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 10,000 years ago into U.S. governmental jargon.

Jim Frost’s picture

By: 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 shot every year even though I know they’re not perfect. I figure they’re a relatively easy and inexpensive way to reduce the chance of having a miserable week.

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