Last week, the Supreme Court heard arguments in the long-awaited preemption case, Wyeth v. Levine.
For the first time, the highest court in the land is weighing in on whether federal approval of a drug preempts tort claims against a drugmaker, such as an injured consumer might bring in a state court. A decision for [...]

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Two weeks ago, Shire received a warning letter for posting a sponsored testimonial on YouTube without including risk information. Shire was very open when I called them up and admitted that the video was posted by accident and immediately removed when it was brought to the company’s attention.
While I’m not 100 percent positive, it [...]

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In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral” complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting [...]

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