fda approval process news

This looks good for drugs like Coramsine. Going into phase 2 trials for renal and melanoma. Most effective drugs do much better against earlier stage cancers.
The FDA emphasized this point in their 11/9/05 Comments on Accelerated Approvals which also stated: (a) that a single well designed clinical trial neither be large nor long for FDA marketing approval (at page 34), and, (b) that the FDA always has the power to withdraw Regular Approval should a post approval Phase 4 trial fail (at pages 59 to 65): http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4191B1_01_02-21CFR-314-601.pdf