http://www.fda.gov/ en http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Fri, 31 May 2024 16:11:56 EDT 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, 31 May 2024 16:10:50 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states 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. Fri, 31 May 2024 16:10:04 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/cleared-510k-submissions-supporting-documents Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date. Fri, 31 May 2024 15:45:19 EDT FDA http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/cleared-510k-submissions-supporting-documents http://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 31 May 2024 15:21:34 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024 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, 31 May 2024 13:18:10 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, 31 May 2024 13:17:18 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances http://www.fda.gov/vaccines-blood-biologics/jynneos Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. <br /> Fri, 31 May 2024 13:03:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/jynneos 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, 31 May 2024 10:26:46 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program Description of CBER&#039;s Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions. Fri, 31 May 2024 10:17:48 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program http://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/support-clinical-trials-advancing-rare-disease-therapeutics-start-pilot-program Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program Fri, 31 May 2024 09:31:05 EDT FDA http://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/support-clinical-trials-advancing-rare-disease-therapeutics-start-pilot-program http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/wcbp-symposium-2024-01232024 WCBP SYMPOSIUM 2024 January 23-25 Thu, 30 May 2024 14:12:22 EDT FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/wcbp-symposium-2024-01232024 http://www.fda.gov/advisory-committees/advisory-committee-calendar/postponed-vaccines-and-related-biological-products-advisory-committee-february-15-2022-meeting This the CBER Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement Thu, 30 May 2024 14:05:08 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/postponed-vaccines-and-related-biological-products-advisory-committee-february-15-2022-meeting 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, 30 May 2024 11:52:05 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/fda-zika-virus-reference-panel-molecular-based-diagnostic-devices-supports-product-testing-emergency Summary of research article for posting on CBER Innovation web site Thu, 30 May 2024 08:57:12 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/fda-zika-virus-reference-panel-molecular-based-diagnostic-devices-supports-product-testing-emergency 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, 30 May 2024 08:19:33 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/vaccines-blood-biologics/cber-2024-orphan-approvals-new-blas CBER 2024 Orphan Approvals Wed, 29 May 2024 17:01:42 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-2024-orphan-approvals-new-blas http://www.fda.gov/news-events/press-announcements/fda-roundup-may-28-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Wed, 29 May 2024 15:14:27 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-28-2024 http://www.fda.gov/science-research/field-science-and-laboratories/field-science-laboratory-manual The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour Wed, 29 May 2024 14:52:08 EDT FDA http://www.fda.gov/science-research/field-science-and-laboratories/field-science-laboratory-manual http://www.fda.gov/news-events/remarks-commissioner-califf-2024-fda-regulatory-education-industry-annual-conference-redi-05292024 Remarks by Robert M. Califf, M.D.<br /> Commissioner of Food and Drugs<br /> 2024 FDA Regulatory Education for Industry Annual Conference (REdI) <br /> May 29, 2024 Wed, 29 May 2024 11:24:54 EDT FDA http://www.fda.gov/news-events/remarks-commissioner-califf-2024-fda-regulatory-education-industry-annual-conference-redi-05292024