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 regulatory action.

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 processes that the food went through to get all the way to those shelves.

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.

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 information to move across the globe. Witness the phenomenon of tools like YouTube, Facebook and LinkedIn, which are allowing consumers to provide instantaneous feedback on their product experience to companies.

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 inboxes, or risk losing all documents contained within them in the future.

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.

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 partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.

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.

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.

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 just part of a broader “systemic” problem with some at the agency.