It’s Not Always Obvious What’s Obvious

If you think it’s easy to determine what’s obvious and what’s not, take a look at the recent Federal Circuit decision in Millennium Pharmaceuticals v. Sandoz. The lower court had determined that a process was obvious. The circuit court held that it was not obvious and that the lower court’s determination …

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Solution to One Problem Brings Two More

An August 2 FDA warning letter provides a reminder that solving one problem can create a new problem—or more. The letter to Coleman Peanut Co., in Petersburg VA, recites that the company uses a cat “as the firm’s pest control.” Presumably, the cat is effective because the letter contains no mention of …

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PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications.  Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed, legislation has been introduced in Congress and a series of legal cases have been brought, …

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Federal Trade Commission Releases New Mobile Health Apps Interactive Tool

The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new web-based interactive tool to assist developers of health-related mobile apps identify …

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Federal Rx for Opioid Epidemic: Tighten Rules on Prescribers

The federal government has made no secret of its concern over what is invariably described as an “opioid epidemic” sweeping the country.  Nor is it a secret that the government sees prescribing physicians—especially primary care physicians—as the best choke point for slowing the flow of …

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OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a …

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