Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/ en Biologics Electronic Reading Room (eFOI) http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoi The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. Wed, 25 May 2022 18:26:03 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoi Virus Entry and Its Inhibition by Antibodies: Studies to Aid the Development and Evaluation of Vaccines that Protect against Viral Infectious Diseases http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/virus-entry-and-its-inhibition-antibodies-studies-aid-development-and-evaluation-vaccines-protect A description of Carol Weiss's research program and related publications. Wed, 25 May 2022 17:16:22 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/virus-entry-and-its-inhibition-antibodies-studies-aid-development-and-evaluation-vaccines-protect 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 Wed, 25 May 2022 15:11:03 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion http://www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-risk-control-strategies-blood-collection-establishments-and-transfusion-services-enhance This is the Guidance for industry, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. - Updated December 2020 Wed, 25 May 2022 12:46:47 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-risk-control-strategies-blood-collection-establishments-and-transfusion-services-enhance FY 2018 Report from the Director http://www.fda.gov/vaccines-blood-biologics/fy-2018-report-director FY 2018 Report from the Director, Dr. Peter Marks Wed, 25 May 2022 11:46:22 EDT FDA http://www.fda.gov/vaccines-blood-biologics/fy-2018-report-director TachoSil http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/tachosil Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Wed, 25 May 2022 11:29:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/tachosil Licensed Biological Products with Supporting Documents 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. Wed, 25 May 2022 10:40:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents Comirnaty and Pfizer-BioNTech COVID-19 Vaccine http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine Tue, 24 May 2022 22:36:27 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine Blood Grouping and Phenotyping Reagents http://www.fda.gov/vaccines-blood-biologics/blood-blood-products/blood-grouping-and-phenotyping-reagents Blood Grouping and Phenotyping Reagents Main Page Tue, 24 May 2022 18:27:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/blood-blood-products/blood-grouping-and-phenotyping-reagents Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal http://www.fda.gov/vaccines-blood-biologics/anti-human-globulin-anti-c3d-ffmu-murine-monoclonal For further manufacturing use in the production of Anti-C3d AHG Blood Grouping Reagent under a Shared Manufacturing Agreement with Diagnostic Grifols, S.A. Tue, 24 May 2022 18:11:35 EDT FDA http://www.fda.gov/vaccines-blood-biologics/anti-human-globulin-anti-c3d-ffmu-murine-monoclonal 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, 24 May 2022 16:34:50 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files OTAT Learn http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn Welcome to OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education. Tue, 24 May 2022 16:29:22 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn Importing CBER-Regulated Products into the United States http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/importing-cber-regulated-products-united-states Importing CBER-Regulated Products into the United States Tue, 24 May 2022 16:12:32 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/importing-cber-regulated-products-united-states Administrative Guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Tue, 24 May 2022 16:04:33 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reduce-possible-risk-transmission-creutzfeldt-jakob-disease-and-variant-creutzfeldt This Level 2 guidance updates the guidance of the same title dated April 2020. Tue, 24 May 2022 14:11:58 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reduce-possible-risk-transmission-creutzfeldt-jakob-disease-and-variant-creutzfeldt Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements http://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-regarding-blood-and-blood-component-donation-suitability-donor-eligibility-and This is the draft guidance Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirementso Tue, 24 May 2022 14:05:41 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-regarding-blood-and-blood-component-donation-suitability-donor-eligibility-and Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy http://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-pressure-and-pulse-donor-eligibility-requirements-compliance-policy This is the draft guidance Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy Tue, 24 May 2022 14:02:52 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-pressure-and-pulse-donor-eligibility-requirements-compliance-policy Antimicrobial Resistance Information from FDA 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, 24 May 2022 12:41:25 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda How to Enter a Certificate of a Pharmaceutical Product (CPP) Application http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-enter-certificate-pharmaceutical-product-cpp-application This is the main page for How to Enter a Certificate of a Pharmaceutical Product (CPP) Application. Tue, 24 May 2022 10:49:27 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/how-enter-certificate-pharmaceutical-product-cpp-application FDA Product Codes For Importing CBER-Regulated Products http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-product-codes-importing-cber-regulated-products FDA Product Codes For Importing CBER-Regulated Products Tue, 24 May 2022 10:32:43 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/fda-product-codes-importing-cber-regulated-products