FDA Offices Sign Deal On Regulatory Authority
4 CommentsBy Ed Silverman // July 3rd, 2008 // 7:45 am
The agreement between the Office of New Drugs and the Office of Surveillance & Epidemiology spells out which unit will take the lead on specific safety issues. And for drugmakers, this is going to be a big change, because the OSE, which was never viewed by pharma as an ally the way the OND has been seen, will have a stronger voice instead of serving as merely a consultant.
They will share equal responsibilty for safety labeling changes; submitting and implementing a risk evaluation mitigation strategy; requiring post-marketing studies and clinical trials; withdrawal of an approved drug; implementing an educational plan and modifying promotion or advertising. OSE will also take the lead in observational epidemiological studies and preventing medical errors.
Hat tip to The RPM Report
Salmon
Gerald,
June 18th, mmmmmmm.
Maybe Congress should look into what happened on June 17th.
Salmon
Salmon
P.S.
While Congress is at it maybe they should look at what happened on June 19th.
Salmon
Salmon
John,
June 30th. Another date Congress might be interested in.
Janet,
I’m surprised you put your signature on this. Does this mean you’re taking responsibility?
P.S. I got the e-mail.
Salmon
Just A Thought
Thanks for this one, Ed.