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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Sen. Burr Worries Rising User Fees Helping US FDA Evade Congressional Oversight
Burr wants more FDA accountability in the new user fee agreements and questions whether they benefit patients. Generic approval modifications get attention at hearing.
US FDA Seeks Ability To Include More Inactive Ingredient, Excipient Info In Brand Labeling
Additions could help streamline generic development, Center for Drug Evaluation and Research Director Patrizia Cavazzoni says.
Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.