Poster
07-20-2004, 03:50 PM
The FDA has proposed to change its approval process and timelines for new and generic drug applications to the process already in use for biological drugs. The FDA would no longer issue an “approval” or “non-approval” letter, but will rather issue a “complete response letter” stating the reasons for any deficiencies in the drug and recommendations the manufacture could take.
The FDA’s goal is to, “ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.”
For more information see: http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=105070
The FDA’s goal is to, “ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.”
For more information see: http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=105070