Monthly Archives: August 2011

Warning Letter and NOV Summary – 2nd Quarter 2011

There has been a lot of commentary about the pick up in enforcement actions by FDA and on the whole, it may be true.  But looking at the Division of Drug Advertising, Marketing and Communications (DDMAC), the increase is not … Continue reading

Posted in FDA Policy | 2 Comments

Weekly Roundup 8-5-11

It was another long, hot week.  The high pressure system over Washington abated somewhat when the Congress actually accomplished something, even though it was something almost no one liked, which apparently saved us from economical disaster, but the market tanked … Continue reading

Posted in Weekly Roundup | Comments Off on Weekly Roundup 8-5-11

TWANK! Pharma Twitter Rankings

This was supposed to happen Monday, but when I hit “Publish” all of the content of the posting disappeared and only the title was sent out.  It was not a good way to start the week.  I have recovered – … Continue reading

Posted in New and Social Media | 4 Comments

A Drug with No Name – Can One Be Approved?

Not long ago, a colleague asked my opinion as to whether or not a drug or biologic could be approved by the FDA even though it still lacked a trade name.  Upon thinking about it, I could recall instances where … Continue reading

Posted in FDA Policy | 1 Comment