FDA Opens Up: Can Industry Live With Greater Transparency?
Drug sponsors are finding little to like about FDA’s transparency initiative - especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency - and FDA’s interest in avoiding another Avandia - industry needs to decide whether this is a fight worth having. This article was originally published in the July/August 2010 issue of The RPM Report.
You may also be interested in...
FDA's transparency initiative is starting to take shape. While many industry executives see the value in making more information available to the public, one idea makes them nervous: publicizing the letters FDA sends when it declines to approve a new drug or biologic. Top FDA officials already support making "complete response" letters public, and the Commissioner's office is open to the idea. How should industry prepare?
Three top FDA officials sat down with The RPM Report at their White Oak campus to discuss the top drug regulatory issues. On the table for discussion: drug safety, comparative effectiveness and the future of drug development.
After an 11-year process, FDA is doing away with "approvable" and "not approvable" letters. . The new name ("complete response") gets rid of the negative connotations of "not approvable". But it is likely to create more confusion-and less transparency--for investors and the public.