http://www.fda.gov/ en http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Mon, 10 Jun 2024 15:57:03 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-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. Mon, 10 Jun 2024 15:56:27 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Mon, 10 Jun 2024 15:56:23 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/vaccines-blood-biologics/casgevy CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs). Mon, 10 Jun 2024 15:17:01 EDT FDA http://www.fda.gov/vaccines-blood-biologics/casgevy http://www.fda.gov/industry/fda-esubmitter/esubmitter-application-history History of all updates to the application software in reverse chronological order by version number Mon, 10 Jun 2024 14:50:53 EDT FDA http://www.fda.gov/industry/fda-esubmitter/esubmitter-application-history http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices. Mon, 10 Jun 2024 13:03:45 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling 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. Mon, 10 Jun 2024 09:36:03 EDT FDA http://www.fda.gov/vaccines-blood-biologics/enforcement-actions-cber/bimoteam-biologicsinternet-surveillanceother http://www.fda.gov/news-events/press-announcements/fda-roundup-june-7-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 07 Jun 2024 15:44:46 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-7-2024 http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-shortages-and-discontinuations A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand. Fri, 07 Jun 2024 13:37:42 EDT FDA http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-shortages-and-discontinuations http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-5-2024-meeting-announcement This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials. Fri, 07 Jun 2024 13:23:00 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-5-2024-meeting-announcement http://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. Fri, 07 Jun 2024 09:20:14 EDT FDA http://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions. Thu, 06 Jun 2024 10:22:26 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/guidance-and-other-information-special-interest-mcm-stakeholders Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases Thu, 06 Jun 2024 09:10:50 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/guidance-and-other-information-special-interest-mcm-stakeholders 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, 06 Jun 2024 08:18:35 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber End of
Translation http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-human-cells-tissues-and-cellular-and-tissue-based-product-hctp-donors-relevant-communicable Testing HCT/P Donors for Relevant Communicable Diseases Wed, 05 Jun 2024 10:45:57 EDT FDA http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-human-cells-tissues-and-cellular-and-tissue-based-product-hctp-donors-relevant-communicable http://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN. Wed, 05 Jun 2024 10:40:55 EDT FDA http://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays http://www.fda.gov/regulatory-information/search-fda-guidance-documents/standardized-format-electronic-submission-marketing-applications-content-planning-bioresearch This is the Draft Guidance for Industry Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions Wed, 05 Jun 2024 08:30:30 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/standardized-format-electronic-submission-marketing-applications-content-planning-bioresearch 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, 04 Jun 2024 14:54:23 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/news-events/press-announcements/fda-roundup-june-4-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 04 Jun 2024 14:28:36 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-4-2024 http://www.fda.gov/regulatory-information/search-fda-guidance-documents/processes-and-practices-applicable-bioresearch-monitoring-inspections Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry Tue, 04 Jun 2024 09:01:14 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/processes-and-practices-applicable-bioresearch-monitoring-inspections