Monthly Archives: September 2007

Weekly Roundup – 9-28-07

The week is at a close.  So is September.  And, a week’s vacation for me at Cape Hatteras also comes to an end.  It was nice, but I’ve had to rely on dial-up, which has made posting to the blog … Continue reading

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Another Approvable Letter Issued – Alcon for Retaane

An approvable letter was issued by the FDA to Alcon for Retaane 15 mg for the treatment of wet-aged macular degeneration (AMD).  Approvable letters are issued when the FDA acknowledges that it is inclined to approval given certain conditions to … Continue reading

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New DTC Oversight Powers Given FDA – Show Me the Money!

I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law.  A new user fee program for review of DTC ads will exist that allows the … Continue reading

Posted in DTC Advertising, FDA Policy, Legislation, Marketing | 1 Comment

Advisory Committee – Conflicts of Interest – FDA Self Reform?

As mentioned last week, compromise legislation passed that is bringing a 5-year extension of PDUFA is also bringing with it a codification on reducing real or perceived conflict of interest rules for members of FDA advisory committees. The legislation sets … Continue reading

Posted in FDA Image, FDA Policy | 2 Comments

PSAs and YouTube – Another Installment on Social Media

I have written several postings in the past on uses of social media by pharmaceuticals.  Just last week, I had a posting on Fard Johnmar’s excellent White Paper on the legal aspects of social media by pharmaceuticals.  One idea that … Continue reading

Posted in Marketing, Social Media | Comments Off