Hello, everyone, and how are you today? Despite the mounting heat enveloping the Pharmalot campus, we are doing just fine, thank you. We actually stay cool by quaffing hot cups of stimulation. We do not have scientific evidence to support out behavior, but the tactic, nonetheless, is successful. So feel free to join us. Meanwhile, we have gathered another bushel of items of interest to help you get started. As always, we hope your journey today is successful and you conquer the world …

The Food and Drug Administration issued a draft guidance that it called “a first step” in encouraging drug companies to study medicines that might be considered for marketing without a prescription. The guidance outlines two approaches for demonstrating safety and effectiveness that may be useful to consider in cases where the product labeling alone is not sufficient to ensure the drug can be used safely and effectively in a nonprescription setting. The first is the development of additional labeling and the second is using technology so consumers can make decisions.

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  • To springboard off the last item above to reply to our scribe’s first comments of the day, as they say on the sub-continent: “Drink hot when it’s hot ….” That is a sufficient anecdotal/ cultural basis for ‘your habit.’ Drink up!

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