federal_register: 03-32255

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03-32255 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Rule The Food and Drug Administration (FDA) is amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids that have standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying 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). 2004-01-05 2004 1 https://www.federalregister.gov/documents/2004/01/05/03-32255/biological-products-bacterial-vaccines-and-toxoids-implementation-of-efficacy-review https://www.govinfo.gov/content/pkg/FR-2004-01-05/pdf/03-32255.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety,...

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