http://www.fda.gov/ en http://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-small-entity-compliance Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide, ,CBER, biologics, guidance, industry, tissue, cell, cellular, compliance Tue, 01 Nov 2022 10:46:45 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-small-entity-compliance http://www.fda.gov/news-events/fda-voices/predicting-stem-cell-activity-ensure-safe-and-effective-therapies Predicting Stem Cell Activity to Ensure Safe and Effective Therapies Mon, 31 Oct 2022 17:05:49 EDT FDA http://www.fda.gov/news-events/fda-voices/predicting-stem-cell-activity-ensure-safe-and-effective-therapies http://www.fda.gov/vaccines-blood-biologics/vaccines/flulaval Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older. Mon, 31 Oct 2022 16:54:12 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/flulaval http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidances This page contains a listing of tissue related guidances. Mon, 31 Oct 2022 16:41:01 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/tissue-guidances http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Mon, 31 Oct 2022 15:56:14 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics 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, 31 Oct 2022 15:54:56 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/devices-guidances This page lists Medical Device Guidance documents. Mon, 31 Oct 2022 15:54:03 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted Novavax COVID-19 Vaccine Mon, 31 Oct 2022 11:46:48 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines Information about Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized. Mon, 31 Oct 2022 10:56:52 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines http://www.fda.gov/vaccines-blood-biologics/vaccines/flucelvax-quadrivalent For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fri, 28 Oct 2022 16:34:11 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/flucelvax-quadrivalent http://www.fda.gov/vaccines-blood-biologics/vaccines/flublok-quadrivalent Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older. Fri, 28 Oct 2022 14:41:58 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/flublok-quadrivalent http://www.fda.gov/vaccines-blood-biologics/vaccines/fluarix-quadrivalent For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fri, 28 Oct 2022 13:51:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/fluarix-quadrivalent 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. Fri, 28 Oct 2022 07:55:23 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological CDER Scientific Reviews Supporting EUA for Therapeutic Products Thu, 27 Oct 2022 18:06:50 EDT FDA http://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological 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. Thu, 27 Oct 2022 17:30:57 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling 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. Thu, 27 Oct 2022 15:43:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents http://www.fda.gov/vaccines-blood-biologics/vaccines/fluarix For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information. Thu, 27 Oct 2022 13:53:35 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/fluarix 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 Thu, 27 Oct 2022 10:59:11 EDT FDA http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviation-reports-annual-summaries 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, 27 Oct 2022 10:12:12 EDT FDA http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-6-2022-meeting-announcement This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement. Thu, 27 Oct 2022 09:45:07 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-6-2022-meeting-announcement