Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and Human Services (HHS) Secretary Ms Kathleen Sebelius says. In testimony before the House Energy and Commerce Committee on 4 February 2010, Ms Sebelius focused on funds included in the budget request for the FDA's efforts to improve medical product safety, including increased inspections and investment in tools to enhance the safety of increasingly complex drugs and biologics.
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Generics
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Biosimilars
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- Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
- ANVISA's role in biosimilar medicine regulation and innovation promotion
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