The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years.
In a review of publicly available RTF letters, researchers at Leerink Swann found that 15 RTF letters were issued from 1998 to 2009 and that there have already been 13 issued since 2009. Among the reasons for given for several RTFs in the last two years.
For More Information Please Click Here: Ask Cato:Is FDA Issuing More Refuse-to-File Letters?
No comments:
Post a Comment