USA – Industry-FDA GDUFA III negotiations seek higher first-round approval rates

Moving on from the kickoff of the 21 July public hearing, the US Food and Drug Administration and representatives of the generics industry have begun substantive negotiations for the terms of reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA).
 
After the first four rounds of negotiations between the US Food and Drug Administration (FDA) and the generics industry, representatives from industry and the FDA have honed in on the pre-facility correspondence program as a place where opportunities lie to decrease time to approval for generic drugs, though fine-tuning remains. (RELATED: FDA kicks off GDUFA III reauthorization process, Regulatory Focus 21 July 2020)
 
The first meeting, held on 17 September, set the ground rules for the virtual GDUFA III negotiations, and introduced FDA and industry representatives. In addition to the Association for Accessible Medicines, industry also had representation from the Bulk Pharmaceutical Task Force and the Pharma and Biopharma Outsourcing Association present at the closed-door negotiations. Though FDA publishes summaries of the meetings in the form of minutes on its website, specifics are not available to the public…