Category Archives: Uncategorized

Weekly Roundup 12-20-13

Yes, I did it.  Cards addressed and sent.  Gifts purchased, wrapped and sent.  The snow in my snow globe descends quietly and peacefully conveying my own inner serenity…. And here is a little of what happened this week, as 2013 … Continue reading

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Optimizing for Mobile – Do It!

Recently a research report by Manhattan Research found that only about a third of pharma web sites have been optimized for mobile use. While I still know people who do not have a smart phone, there aren’t many of them. … Continue reading

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Weekly Roundup – 12-13-13

Ho Ho Ho.  Sort of.  Gifts not yet bought, much less wrapped.  In fact, ideas for buying gifts seem not to be forthcoming.  Cards sitting in their boxes without addresses or messages written inside.  Crowded stores.  No parking.  Traffic.  It … Continue reading

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Draft Guidance on Unsolicited Requests for Off-Label Information

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency on … Continue reading

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DDMAC Enforcement Trickles

For some time there has been speculation that enforcement at FDA is up.  But it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications. For our purposes, … Continue reading

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