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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US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.
Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.
Burr wants more FDA accountability in the new user fee agreements and questions whether they benefit patients. Generic approval modifications get attention at hearing.