Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill
PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.
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Burr wants more FDA accountability in the new user fee agreements and questions whether they benefit patients. Generic approval modifications get attention at hearing.
Additions could help streamline generic development, Center for Drug Evaluation and Research Director Patrizia Cavazzoni says.
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.