The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three years for companies that establish manufacturing operations to manufacture finished generic drugs or active pharmaceutical ingredients (APIs) domestically. However, the pharmaceutical industry has opposed this proposal, arguing that there are more effective ways to enhance domestic manufacturing capacity.
This recommendation was one of four made by FDA as part of the negotiation process to renew the user fee program under Generic Drug User Fee Amendments (GDUFA IV) for fiscal years 2028 to 2032. The proposal was noted in the recent meeting minutes of GDUFA discussions with industry on 7 January...[FDA]
