This post from Pharmalot shows that the number of FDA drug approvals was down again last year - with only 18 new molecular entitites and 3 biologics for a total of 21. Totals for 2009 and 2008 were 26 and 24 respectively.
How Many New Drugs Did FDA Approve Last Year? // Pharmalot.
But....and this is an important BUT......new applications are also down. In 2010, the FDA received 23 applications as compared to 37 in 2009, 34 in 2008 and 35 in 2007. The 23 filed in 2010 was the lowest number filed in past 15 years. For those of you who can do the math, 21 approvals from 23 applications is 91.3%! So much for FDA being solely responsibile for holding up approvals.
If you don't submit applications, you can't get your drug approved seems to be the message.
Posted by Bruce Lehr Feb 18th 2011.
Comments