federal_register: 05-24223
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 05-24223 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order | Notice | The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the United States District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004. The purpose of this final order is to categorize AVA according to the evidence of its safety and effectiveness, thereby determining if it may remain licensed and on the market; issue a final response to recommendations made in the Panel's report, and; respond to comments on the previously published proposed order. The final rule and final order concerning bacterial vaccines and toxoids other than AVA is published elsewhere in this issue of the Federal Register. | 2005-12-19 | 2005 | 12 | https://www.federalregister.gov/documents/2005/12/19/05-24223/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review-anthrax-vaccine | https://www.govinfo.gov/content/pkg/FR-2005-12-19/pdf/05-24223.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The... |