Category Archives: Regulatory Compliance

Hydroponic Operations Fight for Organic Certification Amidst Disapproval from Traditionalists

Hydroponic agriculture is a cutting edge method of growing plants and produce in nutrients which have been dissolved into flowing water. Hydroponic operations have historically fought an uphill battle in their quest to achieve organic certification. In most other developed nations, hydroponic crops cannot be certified as organic, as they are not grown in soil. Between 2001 and 2010, this issue was repeatedly raised to the National Organic Standards Board, which continually held that soil-less systems were inconsistent with organic status, even if they use…

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FDA Cracks Down on Promotional Claims Made on Facebook

In this day and age nearly everyone has a Facebook page, including companies which often use Facebook pages to promote their products and services. Given that Facebook is quite an informal marketing medium, companies may not always scrutinize everything they post as highly as they would more organized or targeted media. But that doesn’t mean the Food and Drug Administration isn’t scrutinizing every wall post and status update. On March 12, 2014, the FDA posted an untitled letter to a Switzerland-based international drug maker, noting…

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Court Reverses Preemption of Medical Injury Suit

A California Appellate Court recently ruled in Coleman v. Medtronic, Inc. that state law tort claims against medical device manufacturers are not preempted by federal law. Medtronic manufactures and sells a medical device called Infuse that is used in spinal surgery. The U.S. Food and Drug Administration granted premarket approval of Infuse for use in certain types of spinal surgery where the incision is made on a patient’s abdomen, but did not approve the device for spinal surgeries where the incision is made on a…

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FDA Rule Proposal Could Lead to Liability for Generic Drug Manufacturers

The U.S. Food and Drug Administration (FDA) is proposing new rule changes that would permit generic drug manufacturers to amend drug warning labels when they receive new information related to drug safety; irrespective of whether the revised labeling differs from the brand name manufacturer. The proposed rules further provide that the generic manufacturer would be required to submit the labeling changes along with the data supporting the change to the FDA, which would review the request and post the data in a public web page.…

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Laser Therapy Lawsuits Increase

A recent study published in the medical journal, JAMA Dermatology, brings to light a   growing number of lawsuits related to cosmetic laser surgery complications. A recurring theme in those lawsuits is that the procedure was performed by a non-physician. The study from researchers at the University of California-Los Angeles (UCLA) used an online national database of public legal documents to determine those that involved laser surgery and non-doctors. They found 175 claims filed between 1999 and 2012. In 43 percent, the error…

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