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
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
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
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
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
