federal_register: 2010-30713
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-30713 | Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate | Notice | The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process. | 2010-12-08 | 2010 | 12 | https://www.federalregister.gov/documents/2010/12/08/2010-30713/biologics-price-competition-and-innovation-act-of-2009-meetings-on-user-fee-program-for-biosimilar | https://www.govinfo.gov/content/pkg/FR-2010-12-08/pdf/2010-30713.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate... |