Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/ en Jobs at the Center for Biologics Evaluation and Research (CBER) 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. Mon, 13 May 2024 00:00:06 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber What’s New for Biologics http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Fri, 10 May 2024 19:27:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Biological Product Deviation Reports Annual Summaries http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviation-reports-annual-summaries Biological Product Deviation Reports Annual Summaries Fri, 10 May 2024 16:10:32 EDT FDA http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviation-reports-annual-summaries FDA Roundup: May 10, 2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 10 May 2024 16:00:03 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024 Patient Listening Session Summaries http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. Fri, 10 May 2024 15:37:52 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Devices Guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances This page lists Medical Device Guidance documents. Fri, 10 May 2024 10:57:46 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances Recently Issued Guidance Documents 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, 10 May 2024 09:49:28 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents FDA Roundup: May 7, 2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Thu, 09 May 2024 14:18:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024 Biologics Electronic Reading Room (eFOIA) http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. Thu, 09 May 2024 12:36:45 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia Consumer Updates http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 09 May 2024 09:50:02 EDT FDA http://www.fda.gov/consumers/consumer-updates Roster of the Vaccines and Related Biological Products Advisory Committee http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee This is the Roster of the Vaccines and Related Biological Products Advisory Committee Thu, 09 May 2024 09:01:27 EDT FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee BIMO/Team Biologics/Internet Surveillance/Other http://www.fda.gov/vaccines-blood-biologics/enforcement-actions-cber/bimoteam-biologicsinternet-surveillanceother This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other. Thu, 09 May 2024 08:32:33 EDT FDA http://www.fda.gov/vaccines-blood-biologics/enforcement-actions-cber/bimoteam-biologicsinternet-surveillanceother Blood Products Advisory Committee May 9, 2024 Meeting Announcement - 05/09/2024 http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-may-9-2024-meeting-announcement-05092024 This is the main page for the Blood Products Advisory Committee May 9, 2024 Meeting Announcement and meeting materials. Thu, 09 May 2024 07:59:43 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-may-9-2024-meeting-announcement-05092024 Administrative Guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Wed, 08 May 2024 16:29:06 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances 2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2024-meeting-materials-vaccines-and-related-biological-products-advisory-committee This is the main page for the 2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC). Wed, 08 May 2024 15:28:52 EDT FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2024-meeting-materials-vaccines-and-related-biological-products-advisory-committee Safety and Efficacy of Immune Globulins and Alpha-1 Proteinase Inhibitors http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/safety-and-efficacy-immune-globulins-and-alpha-1-proteinase-inhibitors A description of Dorothy Scott's research program and related publications. Wed, 08 May 2024 14:59:44 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/safety-and-efficacy-immune-globulins-and-alpha-1-proteinase-inhibitors Virus Entry and Its Inhibition by Antibodies: Studies to Aid the Development and Evaluation of Vaccines that Protect against Viral Infectious Diseases http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/virus-entry-and-its-inhibition-antibodies-studies-aid-development-and-evaluation-vaccines-protect A description of Carol Weiss's research program and related publications. Wed, 08 May 2024 14:51:46 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/virus-entry-and-its-inhibition-antibodies-studies-aid-development-and-evaluation-vaccines-protect Evaluating New Approaches to Developing AIDS Vaccines by Creating Virus-like Particles that Display HIV Antigens or by Using Live, Attenuated (Weakened), non-HIV Viruses to Express HIV Proteins http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/evaluating-new-approaches-developing-aids-vaccines-creating-virus-particles-display-hiv-antigens-or A description of Ira Berkower's research program and related publications. Wed, 08 May 2024 14:50:21 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/evaluating-new-approaches-developing-aids-vaccines-creating-virus-particles-display-hiv-antigens-or Understanding the Interplay Between Host Immunity and Viral Factors for Rational Design of Vaccines Against Vector-Borne Viral Pathogens http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/understanding-interplay-between-host-immunity-and-viral-factors-rational-design-vaccines-against Tony Wang's research project "Understanding the Interplay Between Host Immunity and Viral Factors for Rational Design of Vaccines Against Vector-Borne Viral Pathogens". Wed, 08 May 2024 14:48:23 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/understanding-interplay-between-host-immunity-and-viral-factors-rational-design-vaccines-against Investigating Viruses in Cells Used to Make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/investigating-viruses-cells-used-make-vaccines-and-evaluating-potential-threat-posed-transmission Scientific overview on investigating viruses in cells used to make vaccines and evaluating the potential threat posed by transmission of viruses to humans by Principal Investigator Arifa S. Khan, PhD. Wed, 08 May 2024 14:45:13 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/investigating-viruses-cells-used-make-vaccines-and-evaluating-potential-threat-posed-transmission