federal_register: 00-12116

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
00-12116 Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order Notice The Food and Drug Administration (FDA) is issuing a proposed order to accept the conclusions and recommendations of advisory review panels concerning the safety, effectiveness, and labeling of certain bacterial vaccines and related biological products that were previously classified into Category IIIA (remaining on the market pending further studies in support of effectiveness). On the basis of the advisory review panel findings, FDA is proposing to reclassify the relevant Category IIIA products into Category I (safe, effective, and not misbranded) or Category II (unsafe, ineffective, or misbranded). This action is being taken under the reclassification procedures. 2000-05-15 2000 5 https://www.federalregister.gov/documents/2000/05/15/00-12116/biological-products-bacterial-vaccines-and-related-biological-products-implementation-of-efficacy https://www.govinfo.gov/content/pkg/FR-2000-05-15/pdf/00-12116.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a proposed order to accept the conclusions and recommendations of advisory review panels concerning the safety, effectiveness, and labeling of certain bacterial vaccines and related biological products...

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