Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes
Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.
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The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.