Monthly Archives: November 2006

Tutorial on FDA Approval Outcomes

Every so often, I think it is a good idea to make sure everyone is on the same page for terminology and what it means.  Therefore, today I’m reviewing a few terms and situations.  If you are already knowledgeable about … Continue reading

Posted in Tutorial | 5 Comments

What’s the Track Record on the Fast Track? – Part 1

I thought it a good idea to take a look back at the Fast Track status and get an idea of what the trends have been in this all important category.  Though the chart below is copied from the CDER … Continue reading

Posted in FDA Policy | Comments Off

PDUFA Fees to Raise Money for Ad Reviews

And now, for a commercial break. At the precipice of the Congressional turnover, the FDA has reached a tentative agreement regarding the review by the agency of television commercials. According to the Wall Street Journal last week, pharmaceutical companies would … Continue reading

Posted in DTC Advertising, PDUFA | 2 Comments

Medicare Part D – If it Ain’t Broke, Don’t Fix It

Every so often, unlike some of the more partisan of those in my field, I have to admit when I might be wrong.  It hurts doing it, but afterward, I always feel better.  Plus, you have the added benefit of … Continue reading

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Happy Thanksgiving

Hello everyone. I’m taking the rest of the holiday week off so Eye on FDA will be on hiatus until Monday.  Have a wonderful holiday.  Share this:

Posted in Current Affairs | Comments Off