federal_register: E7-20609
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E7-20609 | Revision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is proposing to amend the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for processing live vaccines is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. | 2007-10-18 | 2007 | 10 | https://www.federalregister.gov/documents/2007/10/18/E7-20609/revision-of-the-requirements-for-live-vaccine-processing-companion-to-direct-final-rule | https://www.govinfo.gov/content/pkg/FR-2007-10-18/pdf/E7-20609.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is proposing to amend the regulations due to advances in technology that... |