GPhA’s Drug Shortage Initiative Clears FTC Hurdle; Still Working With FDA
Five manufacturers have agreed to give IMS Health production and supply information about drugs in short supply; GPhA and IMS are working with FDA to finalize the details of the accelerated recovery initiative.
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Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
In the six months since an executive order encouraged firms to provide early notification of potential shortages, FDA has prevented 128 of them, FDA Commissioner Hamburg reports. She attributes the success to manufacturers’ early notification of potential disruptions in drug supply.
Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’