Category Archives: Uncategorized

A Look Back at 2013 and FDA

Happy New Year!  It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. … Continue reading

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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Draft Guidance on Unsolicited Requests for Off-Label Information

There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency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