AG/FDA Blog

FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time

Some foreign food makers have recently found themselves unceremoniously purged from FDA’s database of registered facilities, and their products stopped at the port. Under the Food Safety Modernization Act (FSMA), all food facilities required to reg… Read More
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FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends

Forewarned is forearmed. For FDA-regulated clinical investigations, knowledge of the most common violations cited by the agency upon inspection is a useful tool for examining one’s own procedures and practices. It helps ensure they are not vulnerab… Read More
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Are These Substances “Natural?” Class Action Lawsuits Target Specific Ingredients

Consumer class action cases challenging “All Natural” or “100% Natural” claims on food labels are popping up about as fast as dandelions in springtime.  Such cases are typically brought under state consumer protection laws prohibiting, inter… Read More
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Food Labeling Politics – What the Election Results May Mean for Your Company

The election is over and the current Administration will stay in the White House. Food labeling may not have been among the top issues on the minds of American voters.  But the election results will have an impact on food manufacturers, retailers, a… Read More
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BPA: The Press Rounds Up the Usual Suspects and Gets it Wrong

By Mark L. Itzkoff Over the past few months, articles have been published claiming possible links between bisphenol A (BPA) and a variety of human health problems including obesity, thyroid changes, and male infertility.  Many of the recent stor… Read More
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Mirror, Mirror on the Wall: Nothing Magical about FDA Warning Letters for Cosmetics with Age-Related Claims

The evil queen sucks the life out of young maidens to sustain her flawless complexion in the movie Snow White and the Huntsman.  If you are wondering how the U.S. Food and Drug Administration (FDA) might regulate the claims for a product with such… Read More
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Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years.  These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws.  As a result… Read More
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OFW Law Drug and Health Care Privacy Practices

OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health… Read More
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The FDA Regulatory Challenges of Software Interoperability and Part 806

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 indu… Read More
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What's Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

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. Th… Read More
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