GDUFA III Talks Completed
Fees will Fund Inspection, Complex Generic Improvements
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
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Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
Industry and regulators need to collaborate to provide complex generics with the opportunity to build even further on the significant contributions already made by off-patent medicines to savings and access, Christine Baeder, senior vice president and chief operating officer of Teva’s US generics division, tells Generics Bulletin in the first part of an exclusive interview.