Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/ en 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 Thu, 02 Feb 2023 16:31:41 EST FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics 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. Thu, 02 Feb 2023 16:26:52 EST FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber 2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2023-meeting-materials-vaccines-and-related-biological-products-advisory-committee This is the main page for the CBER 2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC). Thu, 02 Feb 2023 11:24:21 EST FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2023-meeting-materials-vaccines-and-related-biological-products-advisory-committee Charter of the Cellular, Tissue and Gene Therapies Advisory Committee http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee This is the charter for CBER's Cellular, Tissue and Gene Therapies Advisory Committee. Thu, 02 Feb 2023 10:23:04 EST FDA http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee MedWatch Forms for FDA Safety Reporting http://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online. Thu, 02 Feb 2023 09:56:01 EST FDA http://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting 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. Wed, 01 Feb 2023 15:19:25 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents Administrative Guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Wed, 01 Feb 2023 15:18:53 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances Study Data Technical Conformance Guide - Technical Specifications Document http://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. Wed, 01 Feb 2023 12:22:17 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document 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. Wed, 01 Feb 2023 11:05:15 EST FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Real-World Evidence http://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making. Tue, 31 Jan 2023 15:48:13 EST FDA http://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence Drugs@FDA Data Files 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, 31 Jan 2023 14:42:10 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files Industry (Biologics) http://www.fda.gov/vaccines-blood-biologics/resources-you-biologics/industry-biologics CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Tue, 31 Jan 2023 14:17:58 EST FDA http://www.fda.gov/vaccines-blood-biologics/resources-you-biologics/industry-biologics FAQs: What happens to EUAs when a public health emergency ends? http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends Answers to frequently asked questions about what happens to Emergency Use Authorizations (EUAs), and medical products available under EUA, when a public health emergency ends. Tue, 31 Jan 2023 13:02:59 EST FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends Biologics PREA Reviews and Labeling Changes http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. Tue, 31 Jan 2023 12:53:40 EST FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes Health Fraud Scams http://www.fda.gov/consumers/health-fraud-scams Learn how to spot health fraud and avoid it. Tue, 31 Jan 2023 10:10:11 EST FDA http://www.fda.gov/consumers/health-fraud-scams Biologics Guidances http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances This page displays links to Biologics Guidance documents. Mon, 30 Jan 2023 16:14:54 EST FDA http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2023 http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2023 This is the list of guidance topics CBER is considering for development during Calendar Year 2023 Mon, 30 Jan 2023 16:11:04 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2023 Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023 http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials. Mon, 30 Jan 2023 15:30:32 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement Biological Approvals by Year http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year A collection of biological approval information organized by year and regulatory authorities. Mon, 30 Jan 2023 13:43:32 EST FDA http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human This is the Draft Guidance for Industry Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Mon, 30 Jan 2023 09:22:41 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human