federal_register: 2010-24853

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-24853 Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments Notice The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" (biosimilar) to, or "interchangeable" with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency's implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act. 2010-10-05 2010 10 https://www.federalregister.gov/documents/2010/10/05/2010-24853/approval-pathway-for-biosimilar-and-interchangeable-biological-products-public-hearing-request-for https://www.govinfo.gov/content/pkg/FR-2010-10-05/pdf/2010-24853.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act...

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