http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-april-30-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Wed, 01 May 2024 17:00:41 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-30-2024 http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Wed, 01 May 2024 16:59:13 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics 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, 01 May 2024 16:03:40 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/international-activities/foreign-regulator-information-exchanges In support of this mission element, the FDA’s Center for Biologics Evaluation and Research (CBER) exchanges critical regulatory information on an on-going basis with foreign regulatory counterparts using a range of mechanisms. CBER undertakes information exchanges with counterparts in the Americas, Wed, 01 May 2024 15:31:30 EDT FDA http://www.fda.gov/vaccines-blood-biologics/international-activities/foreign-regulator-information-exchanges http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin For the treatment of High-grade, Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer. Wed, 01 May 2024 14:24:55 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin 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. Wed, 01 May 2024 10:17:48 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/drugs/drug-approvals-and-databases/drugsfda-data-files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Tue, 30 Apr 2024 14:54:18 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-human-allogeneic-cells-expanded-use-cell-based-medical-products This is the draft guidance Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products Tue, 30 Apr 2024 13:07:01 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-human-allogeneic-cells-expanded-use-cell-based-medical-products http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. Tue, 30 Apr 2024 13:00:42 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue This is the draft guidance Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products Tue, 30 Apr 2024 12:51:21 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances This page contains a listing of Blood Guidances guidances. Tue, 30 Apr 2024 10:04:38 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-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. Tue, 30 Apr 2024 10:04:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-use-standard-uniform-blood-and-blood-component-container-labels We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable for use by you, manufacturers of blood and blood components, subject to United States statutes and regulations, the document entitled “United States Industry Consensus Standard for the Uniform Labeling Tue, 30 Apr 2024 10:02:36 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-use-standard-uniform-blood-and-blood-component-container-labels http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more. Mon, 29 Apr 2024 11:33:23 EDT FDA http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Mon, 29 Apr 2024 11:21:31 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice At the FDA, we rely on our many advisory committees to help us make sound decisions based on the best science available. Advisory committees give our own FDA experts outside, independent, and professional advice on various complex scientific, technical, and policy issues. Mon, 29 Apr 2024 11:03:14 EDT FDA http://www.fda.gov/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats. Mon, 29 Apr 2024 10:06:34 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances This page contains a listing of cellular and gene therapy guidances. Mon, 29 Apr 2024 08:12:01 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances 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, 26 Apr 2024 17:38:15 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products Listing of licensed and approved products from the Office of Tissues and Advanced Therapies (OTAT). Fri, 26 Apr 2024 16:11:22 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products