Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21. Known as the 21st Century Cures Act (“Act”),
Device Firms: What You Should Know About The 21st Century Cures Act Read More »
In the month of May, Texas received over 35 trillion gallons of rain. See the graphic, below, to put that into perspective. Many prayers were answered as we went from extreme drought to an overabundance of rainfall. Truly a blessing! It is much more difficult to do without water than deal with having too much.
How Much Rain Has Fallen In Texas? Read More »
By Marshall, as published in Agri-Pulse In a surprise upset, Dr. Akinwumi (Akin) Adesina was elected to be the next President of the African Development Bank (ADB), defeating seven rivals in six rounds of voting. Adesina holds a PhD in agriculture economics from Purdue and has been serving as the Minister of Agriculture in Nigeria since
Why Adesina’s Election is Important for Agriculture Read More »
We are pleased to announce that Nancy Nord, former Acting Chair of the United States Consumer Product Safety Commission, has joined OFW Law as Of Counsel. Nord is a nationally recognized expert on safety regulation and corporate compliance with a wealth of experience in both the public and private sectors. Please click the announcement, below,
Former Consumer Products Safety Commissioner Nancy Nord Joins OFW Law Read More »
By Elliot Belilos The U.S. Consumer Product Safety Commission (CPSC) recently filed an action in federal court against Michaels Stores, Inc., seeking civil penalties for allegedly untimely reporting injuries from a vase sold in the stores and, notably, for allegedly falsely reporting the incidents as a retailer rather than as the manufacturer of the product. According
CPSC Enforcement Action Against Michaels Highlights Importance of Proper Reporting Read More »
By John R. Block We can’t seem to silence or satisfy the loud scream of opposition to GE crops. The reason probably is that up until now we have ignored them. It’s time to stand up and set the record straight. GE food is safe and even beneficial according to 88% of scientists. We have conducted
John Block: GMOs Under Assault Read More »
By John R. Block As a farmer, we understand that if you have something that doesn’t work, you fix it. It will just cost you money if you ignore the problem. Somehow, the federal government doesn’t seem to understand that common sense fact. The Country of Origin Labeling (COOL) law was first passed in 2002. Canada
John Block: “COOL” Isn’t Cool Read More »
Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here. The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals. Though FDA has been actively implementing Title
FDA Releases Draft Guidance on Compounding Animal Drugs Read More »
By Marshall L. Matz, as published in Agri-Pulse Michael B. Jandreau, the visionary leader of the Lower Brule Sioux Tribe in South Dakota for almost 40 years, passed away last month at the age of 71. Known to all as “Mike” he believed that Indian Tribes had to establish a private sector economy on the Reservations if
Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA). The webinar is sponsored by the Healthcare Distribution Management Association (HDMA). This “DSCSA Overview for Dispensers” continues HDMA’s education and outreach on the pharmacy and hospital–related implementation requirements under the DSCSA. Particular focus
May 19 Webinar on the Drug Supply Chain Security Act Read More »
By John R. Block I was on the farm last week and early this week. My timing was right. I wanted to be there for the corn planting. We finished and started on soy beans. I have never seen the seeds go in the ground under better conditions. That rich, black dirt was not cloddy, not
John Block: Down on the Farm Read More »
By Elliot Belilos In the wake of the recent 60 Minutes piece that highlighted alleged elevated formaldehyde in the Chinese-made wood flooring imported by Lumber Liquidators, all manufacturers and importers of consumer products containing compressed wood need to ensure that their products comply with the California Air Resources Board (CARB) limits regarding formaldehyde emissions. And while
Spotlight on Compliance of Wood Products Read More »
By John R. Block The U.S. Supreme Court decides a lot of very serious, high-profile cases – gay marriage for example. However, recently, they heard one about raisins. Yes – raisins. The Raisin Program dates back to the Great Depression of the 1930s. President Roosevelt cut the production of many farm products to reduce surplus and
John Block: Raisins Read More »
By Barbara J. Masters, D.V.M. How many of you have ever sat in a public location, such as the airport, and watched the number of people that enter the restroom talking on their cell phone? Creepy, huh? Not nearly as creepy as the same number of people that exit a very short time later still talking
Hand Washing: A Simple Step Read More »
By Robert A. Hahn The FDA’s food labeling regulations include some traps for the unwary. A few of those traps have to do with the net quantity of contents declaration. Here are a couple of points to keep in mind when declaring a food product’s net contents: When the net contents declaration is expressed in terms
Clearing Up Confusion: The Net Quantity of Contents Declaration on Food Labels Read More »
By Barbara J. Masters, D.V.M. One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.” The Agency has a FY 2015 target of 90% of all establishments having a
Food Defense Plans Read More »
By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional
FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data Read More »
