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Latest From Ortho-McNeil Inc.
In suit against FDA, Amgen argues it provided sufficient data to obtain exclusivity for Sensipar but agency says too few patients were included in one study; court ruled against FDA in similar 2001 dispute.
COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process
FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.
How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.
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