federal_register: 04-28322
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-28322 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is proposing to classify these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004. The court vacated the January 5, 2004 (69 FR 255) final rule. Therefore, elsewhere in this issue of the Federal Register, FDA is withdrawing the January 5, 2004, final rule. FDA is issuing this proposed rule and proposed order again to provide notice and to give interested persons an opportunity to comment. | 2004-12-29 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/29/04-28322/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review | https://www.govinfo.gov/content/pkg/FR-2004-12-29/pdf/04-28322.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 in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and... |