Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.
The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.