federal_register: 2011-15346
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-15346 | Amendments to Sterility Test Requirements for Biological Products | Proposed Rule | The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations. | 2011-06-21 | 2011 | 6 | https://www.federalregister.gov/documents/2011/06/21/2011-15346/amendments-to-sterility-test-requirements-for-biological-products | https://www.govinfo.gov/content/pkg/FR-2011-06-21/pdf/2011-15346.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most... |