Importation Should Be Preemptive Tool During Shortages, Group Tells FDA
Executive Summary
The Greater New York Hospital Association, in a meeting with FDA Commissioner Margaret Hamburg, says the agency should be more proactive when considering importation of unapproved drugs to mitigate a shortage.
You may also be interested in...
Germany’s New Drug Register To Help Tackle Supply Shortages, But Larger EU Problem Looms
The new German drug register is designed to be a first step in tackling potential drug shortages on the domestic market, but it currently lacks effective solutions.
FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin
The 11-member staff CDER devotes to drug shortages is moving to the Office of the Center Director and will report to Deputy Director for Regulatory Programs Doug Throckmorton.
Economics Of Gaining Approval For Unapproved Phenylephrine Remains Question Mark
West-Ward could be the first to gain approval for phenylephrine in hypotension, but the drug’s widespread use as a stand-by medication during surgery could deter FDA enforcement against unapproved versions.