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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Generic Policy Tweaks In Omnibus Legislation Include Processes Improvements On Late-Stage Label Changes, 505(b)(2) TE Designations
FDA will be able to approve some interchangeable biosimilars more smoothly, but won’t be instructed to provide ANDA sponsors with more information on the inactive ingredients in brand drugs.
US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation
Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.
User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.