By Brett T. Schwemer, as published in the October 2012 issue of The National Provisioner. This summer, the focus of the U.S. Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS) has clearly been on the control of Shiga-toxin producing E. coli and Salmonella in certain raw meat or poultry products. However, a recent FSIS Notice […]
Updated FSIS Guideline Refocuses Attention on Listeria Control Read More »
By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device
The FDA Regulatory Challenges of Software Interoperability and Part 806 Read More »
Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not
Abraham Lincoln’s Convention: Chicago 1860, compiled and presented by OFW Law’s very own Kenneth D. Ackerman, is now available! An eBook original and part of a series called History Shorts/Original Voices, it tells the story of Lincoln’s surprise nomination primarily through the eyes of newspaper writers, giving it the immediacy of the moment, with annotations, background,
Abraham Lincoln’s Convention: Chicago 1860, by Kenneth D. Ackerman…Now Available! Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. We just returned from summer vacation to the Baltic, including St. Petersburg, Russia. Mother Russia hasn’t really changed all that much since the Soviet days. There are beautiful palaces, exquisite waterways, and art treasures galore. There are security cameras
John Block Reports: A Visit to St. Petersburg / Back in the USSR Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Reaching new lows in broadcast television journalism, ABC News several weeks ago ran an investigative report unfairly and inaccurately disparaging a safe and wholesome lean beef product by repeatedly referring to it as “pink slime.” They sent out their
John Block Reports: Tabloid Journalism – ABC News Slimes Lean Beef Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Remember, I’m Jack’s moderate Democrat colleague. We support the same priorities – a healthy and prosperous agricultural sector. With the Presidential election beginning to heat up, I thought I would lay out the case for why President Barack Obama
John Block Reports: The Case for Obama Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. The bad news just keeps rolling in. The unemployment rate rests at 9% with over 400,000 new applicants each week. Worse yet, many folks are simply leaving the work force and not trying at all. Our GNP has flat-lined
John Block Reports: Pain and Productivity Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Over the past 35 years, I have acted as food safety counsel to a wide array of agriculture interests in the United States including producers, processors, distributors and retailers. The concepts of food poisoning and food borne illness were
John Block Reports: Holiday in Europe – Food Safety Gets Personal Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Recently, Congress enacted new laws to bolster food safety and to require calorie labeling for restaurant foods. Both of these laws had broad industry and consumer support. Now, Congress is debating FDA’s budget for 2012 and some in the
John Block Reports: Don’t Cut the FDA Budget Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Last week the President signed the Food Safety Modernization Act. It was passed by a united lame-duck Congress in the waning days of 2010. The new food safety law enhances FDA’s authority to make an already safe food supply
John Block Reports: Food Safety Legislation Enhances Already Safe Food Supply Read More »
OFW Law founding principal Richard L. Frank sits in with former USDA Secretary John R. Block on John Block Reports. The election is now over. Yes, Republicans have made significant gains, reclaiming the House and gaining a virtual tie in the Senate. Nancy Pelosi is out and John Boehner is in. Harry Reid’s already weakened authority has been further diminished and
John Block Reports: Time for Leadership Read More »
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