http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Dec 2023 16:46:57 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-december-1-2023 http://www.fda.gov/vaccines-blood-biologics/allergenics/odactra Product approval information for use in adults 18 through 65 years of age as immunotherapy for house dust mite- (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust m Fri, 01 Dec 2023 16:05:51 EST FDA http://www.fda.gov/vaccines-blood-biologics/allergenics/odactra http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Fri, 01 Dec 2023 16:02:03 EST FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics 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. Fri, 01 Dec 2023 15:56:17 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states 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. Fri, 01 Dec 2023 10:05:10 EST FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-26-2021-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement. Thu, 30 Nov 2023 13:50:20 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-26-2021-meeting-announcement http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement. Thu, 30 Nov 2023 10:22:18 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement. Thu, 30 Nov 2023 10:21:23 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-april-15-2021-meeting-announcement-04152021 This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement. Thu, 30 Nov 2023 10:18:22 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-april-15-2021-meeting-announcement-04152021 http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-september-2-3-2021-meeting-announcement This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement. Thu, 30 Nov 2023 10:17:18 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-september-2-3-2021-meeting-announcement http://www.fda.gov/vaccines-blood-biologics/vaccines/fluzone-quadrivalent-fluzone-high-dose-quadrivalent-fluzone-intradermal-quadrivalent-fluzone For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Thu, 30 Nov 2023 10:08:06 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/fluzone-quadrivalent-fluzone-high-dose-quadrivalent-fluzone-intradermal-quadrivalent-fluzone http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-november-4-2021-meeting-announcement-11042021 This is the CBER Blood Products Advisory Committee November 4, 2021 Meeting Announcement. Thu, 30 Nov 2023 09:57:15 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-november-4-2021-meeting-announcement-11042021 http://www.fda.gov/advisory-committees/blood-products-advisory-committee/2021-meeting-materials-blood-products-advisory-committee This is the main page for the CBER 2021 Meeting Materials, Blood Products Advisory Committee. Thu, 30 Nov 2023 09:51:53 EST FDA http://www.fda.gov/advisory-committees/blood-products-advisory-committee/2021-meeting-materials-blood-products-advisory-committee http://www.fda.gov/advisory-committees/advisory-committee-calendar/allergenic-products-advisory-committee-october-28-2021-meeting-announcement-10282021 This is the main page for the CBER Allergenic Products Advisory Committee October 28, 2021 Meeting Announcement. Thu, 30 Nov 2023 09:44:17 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/allergenic-products-advisory-committee-october-28-2021-meeting-announcement-10282021 http://www.fda.gov/news-events/speeches-fda-officials/remarks-commissioner-robert-califf-national-consumer-league-health-advisory-council-winter-meeting Remarks by Robert M. Califf, M.D.<br /> Commissioner of Food and Drugs<br /> National Consumer League Health Advisory Council Winter Meeting<br /> Nov. 29, 2023 Thu, 30 Nov 2023 08:10:16 EST FDA http://www.fda.gov/news-events/speeches-fda-officials/remarks-commissioner-robert-califf-national-consumer-league-health-advisory-council-winter-meeting http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/warrior-families-advancing-regenerative-medicine-through-science-10052023 The webinar, Warrior Families: Advancing Regenerative Medicine Through Science, will feature a panel of families sharing their experiences with advocacy and contributing to therapeutic product development for children living with rare diseases. Wed, 29 Nov 2023 15:31:48 EST FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/warrior-families-advancing-regenerative-medicine-through-science-10052023 http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances This page lists Clinical Guidance documents. Wed, 29 Nov 2023 15:15:24 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Wed, 29 Nov 2023 15:14:52 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2021-meeting-materials-vaccines-and-related-biological-products-advisory-committee This is the main page for the CBER 2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC). Wed, 29 Nov 2023 14:13:19 EST FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2021-meeting-materials-vaccines-and-related-biological-products-advisory-committee http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-4-2020-meeting-announcement This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement. Wed, 29 Nov 2023 14:07:07 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-4-2020-meeting-announcement