Food Defense Plans

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… Read More
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FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data

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Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Condu… Read More
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Warning Letters Update

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to e… Read More
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Food Facility Registration Rules To Be Updated by FDA

FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essen… Read More
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FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm”

In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm.  Even now, to my husband’s dismay, I have never outgrown being “horse crazy.”  But during all this time, I never remember being concerned abo… Read More
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Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at Read More
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Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition. GCNF’s Annual Gala has become a signature Washington event, bringing together executiv… Read More
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