http://www.fda.gov/ en http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-15-2023-meeting-announcement This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials. Thu, 01 Jun 2023 13:14:01 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-15-2023-meeting-announcement http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states The product name and trade name of vaccines licensed for use in the United States. Thu, 01 Jun 2023 12:38:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Thu, 01 Jun 2023 12:31:27 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 01 Jun 2023 10:45:20 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics. Thu, 01 Jun 2023 09:49:42 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-and-nihnci-center-cancer-research-advancing-drug-development-myelodysplastic-syndromes-05162023 FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes. Virtual 2-day free public workshop. Thu, 01 Jun 2023 06:55:55 EDT FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-and-nihnci-center-cancer-research-advancing-drug-development-myelodysplastic-syndromes-05162023 http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert. Wed, 31 May 2023 23:16:26 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents http://www.fda.gov/news-events/press-announcements/fda-roundup-may-30-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 30 May 2023 16:02:55 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-30-2023 http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Tue, 30 May 2023 14:42:38 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/vaccines-blood-biologics/data-cyte-plus-reverse-cyte-search-cyte-reagent-red-blood-cells-stn-103898 Reagent Red Blood Cells Approval Page Tue, 30 May 2023 13:37:03 EDT FDA http://www.fda.gov/vaccines-blood-biologics/data-cyte-plus-reverse-cyte-search-cyte-reagent-red-blood-cells-stn-103898 http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-vaccines Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint Tue, 30 May 2023 11:18:02 EDT FDA http://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-vaccines http://www.fda.gov/drugs/accelerated-approval-program/ongoing-infectious-disease-accelerated-approvals-vaccines Biologic Accelerated Approvals Based on a Surrogate Endpoint Tue, 30 May 2023 11:17:00 EDT FDA http://www.fda.gov/drugs/accelerated-approval-program/ongoing-infectious-disease-accelerated-approvals-vaccines http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccines FDA authorized bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including an additional dose or doses for certain populations Tue, 30 May 2023 10:13:28 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccines http://www.fda.gov/news-events/press-announcements/fda-roundup-may-26-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 26 May 2023 15:38:12 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-26-2023 http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Fri, 26 May 2023 14:18:29 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Fri, 26 May 2023 14:17:45 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/immune-globulin-hypersensitivity-reactions-root-causes-and-mitigation-public-workshop-03302023 Immune Globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of Immune Globulins (IG). Fri, 26 May 2023 13:47:46 EDT FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/immune-globulin-hypersensitivity-reactions-root-causes-and-mitigation-public-workshop-03302023 http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/application-submissions-guidances This page lists Application Submissions Guidance documents. Fri, 26 May 2023 13:37:26 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/application-submissions-guidances http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological CDER Scientific Reviews Supporting EUA for Therapeutic Products Fri, 26 May 2023 08:16:56 EDT FDA http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Thu, 25 May 2023 16:48:26 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines