Monthly Archives: October 2007

Draft Guidance on Conflict of Interest for Advisory Committees Issued by FDA

The Food and Drug Administration today is scheduled to publish a Draft Guidance in the Federal Register entitled Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and DRug Administration Staff:  Public Availability of Advisory … Continue reading

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Joe Biden – Where the Candidates Stand, Part I in a Series

There are 65 days left to the Iowa Caucus.  As I mentioned last week, I intend to profile the healthcare positions of each of the candidates as those positions might affect the workings of the FDA and the pharmaceutical market.  … Continue reading

Posted in Current Affairs | 2 Comments

The New Prescription Drug User Fee Program for DTC for Drug and Bio Products

Tomorrow, the FDA will be publishing a Notice entitled the "User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and nUmber of Advertisements for Review" – A MOUTHFUL!  … Continue reading

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Another OTC Attempt for Mevacor

In July of 2000, two companies tried to take statins from RX to OTC.  The first was Bristol Myers Squibb attempting to switch Pravachol and the other was Merck trying to switch Mevacor.  Today, there is a Federal Register notice … Continue reading

Posted in OTC Switches | 1 Comment

Where Do the Candidates Stand?

Since 2000, more than 7 million Americans have entered the ranks of the uninsured. Today, healthcare, and its related elements, are the number two concern among voters. We have no shortage of candidates, though the ranks grew smaller last week … Continue reading

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