The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal, the agency's efforts to protect itself from naysayers have contributed significantly to the low number of new drugs approved in 2007. So far this year, the FDA has approved only 15 new molecular entities (NMEs) and is on track to approve about 18 by December. That's down from 22 NMEs in 2006, 20 in 2005 and 36 in 2004.
- read this summary for more
- see the full WSJ article
PLUS: The bad news for the FDA keeps getting worse. Testifying before Congress, a GAO director said the FDA can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax. Report
Related Articles:
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report
Overseas drugmaking goes unsupervised. Report