Posted: March 25, 2014 - 3:00 pm ET
The Food and Drug Administration wants drugmakers to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked.
A new FDA guidance (PDF) seeks to clarify how drugs approved through the accelerated approval pathway should be labeled. The pathway in question is used to expedite the approval of medicines intended to treat serious or unmet needs. For instance, if there is a promising drug for a certain type of cancer that shows some early signs of benefit, that product could receive tentative accelerated approval.
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