AG/FDA Blog

POM Wonderful vs. FTC: The Epic War Continues

There are some spectacles we geeks in the food and drug bar follow as avidly as any mini-series. The epic, two-year battle between POM Wonderful (producer of pomegranate products) and the Federal Trade Commission (FTC) is almost as addictive as HBO… Read More
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Deadly Meningitis Outbreak Linked To Compounded Steroid— The Tipping Point For Compounders?

Five people are dead and another 35 are very ill due to a fungal meningitis outbreak in six states.  The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) have traced the outbreak to the New England Comp… Read More
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California’s Prop 37 -- A Prop Too Far?

On election day, California voters will decide on another food labeling ballot initiative, one that is being watched intently by the food industry.  If it passes, the California Right to Know Genetically Engineered Food Act, popularly known as “Pr… 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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A Double Espresso Morning

It’s a busy day here and I’m wishing for an IV espresso drip and a neural Twitter implant.  I’m following the Federal Trade Commision (FTC) Pet Meds webcast and the Food and Drug Law Institute (FDLI) Advertising and Promotion Workshop while my… Read More
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Veterinary Drug Distribution

As I write this, my Labrador is gutting a stuffed mouse at my feet.  I’ll need to take the toy from her shortly to avoid her enthusiastic consumption of the squeaker within (and what I know, from experience, can be a very costly aftermath of emer… 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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