Monthly Archives: December 2006

It is Raining Approvable Letters

Apparently, the FDA is finishing up business for 2006 with a spate of activity.  In addition to the three approvable letters noted last week, the FDA issued another approvable letter today to Nuvo Research Inc., Yahoo reports, for a topical … Continue reading

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Hiatus Interruptus – Advisory Committees Set Meeting Dates

Hi there.  I know I was taking this week off for vacation, but it hasn’t worked out that way.  After a quick trip to the family, a 14 hour return drive, instead of R&R, I’m working again.  So here is … Continue reading

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Three Approvable Letters Issued This Week

Not all companies are getting what they want for Christmas.  Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to three companies.  Remember that receipt of … Continue reading

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Holiday Hiatus

Hello everyone. Eye on FDA is going on holiday hiatus for the balance of the year.  We will be back in January with a few new features. Have a wonderful holiday. Share this:

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Keeping an Eye on Adverse Events

This week, the FDA updated its quarterly reporting on Adverse Events.  It is a bit of a complicated mess to work your way through.  But there are other ways to look at adverse events and given that there have recently … Continue reading

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