This is an update to BioMedTracker’s 2007 FDA Approval Report. We have evaluated the overall number of approvals using data from the U.S. Food and Drug Administration (FDA) on original new drug applications (NDA), new molecular entities (NME) and biologic license applications (BLA). Utilizing data from BioMedTracker, approval rates from 2008-2009 were compared to the data presented in our previous report. New to the report are sections on action dates not met (where the FDA failed to meet a PDUFA deadline), Food and Drug Administration Amendments Act (FDAAA) and Risk Evaluation and Mitigation Strategy (REMS) programs, as well as FDA advisory panel meetings. In addition, we have included approval decisions by disease group, upcoming 2010 PDUFAs and the magnitude of price movements around PDUFA dates from 2008 and 2009.

Key Points:

• The number of drugs being approved has risen from the record low of 2007
• NME and BLA approvals have shown particular strength
• Despite an increase in approvals, the overall approval rate per FDA decision has remained low
• New requirements from FDAAA have led to increased approval timelines and delays
• Key Phase III data in 2009 has led to high profile 2010 PDUFAs to come

For the full report, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.