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FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]

If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

Legal review of concierge medicine contracts is needed to handle regulatory issues & liability risks, as otherwise medical doctors opening concierge practices risk triggering all sorts of [...]

Is an online directory of healthcare centers a medical referral service? We’ve had several online directories of healthcare services ask us what legal rules govern their operation. Below we [...]