Monthly Archives: December 2008

DTC in the Crosshairs of Congressman Waxman

Reuters carried a report yesterday confirming not only that a moratorium on Direct-to-Consumer (DTC) advertising is likely to be introduced in the next Congress, but is going to be broached by Congressman Henry Waxman, the new Chair of the House … Continue reading

Posted in DTC Advertising | 1 Comment

FDA Approval Track Record Since Advent of Complete Response Letters

It has been four months since FDA's CDER began issuing Complete Response Letters in place of Approvable or non-approval letters.  Looking back to August to get an idea of where we are in terms of the approval of new molecular … Continue reading

Posted in Approvable Letters, FDA Policy | 1 Comment

Weekly Roundup – 12/05/08

Are you ready?  The scaffolding at the Capitol building is nearly complete.  The changes are poised to happen.  If you haven't already, catch up on my perspective on the changes on the EyeonFDA YouTube channel with videos of my 3-part … Continue reading

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The Tom Daschle Appointment for HHS – What’s Inside?

Former Senate leader Tom Daschle has been tapped by President-Elect Barack Obama as the new Secretary of Health and Human Services.  Here is some of the legislation Senator Dashcle either sponsored or co-sponsored related to FDA and to the pharmaceutical … Continue reading

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The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 3

Here is the last of the 3-part series about the impact of expected upcoming changes in the policy environment and the tremendous migration in the communications environment and  how this affects the marketing of pharmaceutical products.  In this last installment, … Continue reading

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