Pages

▼
Showing posts with label FDA postmarket controls. Show all posts
Showing posts with label FDA postmarket controls. Show all posts
Friday, April 08, 2011

Time to Retire “Post-Marketing”?

›
FDA’s recently published guidance on Post Marketing Studies and Clinical Trials is a study in the importance of the mot juste . The guidance...
1 comment:
Thursday, October 21, 2010

Wolfe vs. Rappaport (Part 2): Embeda Warning Letter Raised During Abuse-Resistant Opioids Ad Comm

›
Advisory committees are always interesting, but you really have to expect the unexpected when Public Citizen Health Research Group Director ...
Tuesday, August 18, 2009

Onglyza and the Type 2 Diabetes Approval Path: The Map is Still Sketchy

›
Biopharma companies hoping to develop drugs to compete in the type 2 diabetes market can breathe a bit easier with the approval of Bristol-...
Friday, August 22, 2008

A Better Way to do Risk/Benefit? (Part 2)

›
As we discussed yesterday, FDA is taking a small step towards a potentially revolutionary goal: developing a more formal, systematic approac...
2 comments:
Thursday, August 21, 2008

A Better Way to do Risk/Benefit? (Part 1)

›
Our sharp-eyed colleagues at “The Pink Sheet” spotted an interesting document last week: a request for proposals issued by the Food & ...
1 comment:
Thursday, May 22, 2008

Entereg Approved at Last

›
Perspective is an amazing thing. In June 2004, Adolor Corp. filed a new drug application for alvimopan ( Entereg ) for treatment of postoper...
Wednesday, May 14, 2008

The Fentora Rejection (Part II): Primacy of Postmarket Plans

›
Cephalon’s tough advisory committee review on May 6 for the expanded indication to non-cancer breakthrough pain for Fentora (fentanyl bucca...
1 comment: