http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-roundup-march-1-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 01 Mar 2024 15:58:34 EST FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-1-2024 http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Fri, 01 Mar 2024 14:27:50 EST 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. Fri, 01 Mar 2024 14:26:12 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances This page lists Clinical Guidance documents. Fri, 01 Mar 2024 14:25:54 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Fri, 01 Mar 2024 11:49:09 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances http://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-investigational-drug-or-biologic Emergency Use of an Investigational Drug or Biologic - guidance Fri, 01 Mar 2024 11:08:41 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-investigational-drug-or-biologic http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Fri, 01 Mar 2024 10:57:13 EST FDA http://www.fda.gov/consumers/consumer-updates 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. Fri, 01 Mar 2024 10:07:12 EST FDA http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics http://www.fda.gov/news-events/fda-voices/fda-works-make-informed-consent-easier-understand FDA and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” Fri, 01 Mar 2024 09:33:20 EST FDA http://www.fda.gov/news-events/fda-voices/fda-works-make-informed-consent-easier-understand http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/information-health-professionals-partial-heart-transplantation The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regulates human cells, tissues, and cellular and tissue-based products, or HCT/Ps. These include tissues derived from organs. Fri, 01 Mar 2024 09:06:05 EST FDA http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/information-health-professionals-partial-heart-transplantation http://www.fda.gov/consumers/consumer-updates/vaccination-best-protection-against-measles Measles is not a harmless childhood disease. It&#039;s dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with a measles vaccine. Vaccines approved by the FDA for the prevention of measles are proven both safe and effective. Fri, 01 Mar 2024 08:12:58 EST FDA http://www.fda.gov/consumers/consumer-updates/vaccination-best-protection-against-measles http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) March 5, 2024 Meeting announcement and meeting materials. Fri, 01 Mar 2024 08:01:29 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products CBER regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. Thu, 29 Feb 2024 19:41:04 EST FDA http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/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, 29 Feb 2024 13:26:13 EST FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/licensed-biological-products-supporting-documents 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. Thu, 29 Feb 2024 12:41:53 EST FDA http://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays http://www.fda.gov/vaccines-blood-biologics/hepatitis-b This page contains Hepatitis B infectious disease tests with supporting documents Thu, 29 Feb 2024 12:32:11 EST FDA http://www.fda.gov/vaccines-blood-biologics/hepatitis-b http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/elecsys-anti-hcv-ii Intended Use for Elecsys Anti-HCV II<br /> Elecsys Anti-HCV II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. Elecsys Anti-HCV II is intended to screen individual human donors, including volunteer donors of whole blood, ... Thu, 29 Feb 2024 12:08:22 EST FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/elecsys-anti-hcv-ii http://www.fda.gov/news-events/fda-voices/fda-helps-deliver-meaningful-advances-rare-disease-patients We remain committed to supporting rare disease research, engaging patients and caregivers to understand their unique perspectives, and enhancing our review processes to advance medical products for rare disease patients. Thu, 29 Feb 2024 11:21:35 EST FDA http://www.fda.gov/news-events/fda-voices/fda-helps-deliver-meaningful-advances-rare-disease-patients http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/elecsys-hbsag-ii-and-elecsys-hbsag-ii-auto-confirm Intended Use for Elecsys HBsAg II Immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma.<br /> Intended Use for Elecsys HBsAg II Auto Confirm Immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen.. Thu, 29 Feb 2024 11:16:12 EST FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/elecsys-hbsag-ii-and-elecsys-hbsag-ii-auto-confirm http://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-antibody-drug-conjugates-guidance-industry Clinical Pharmacology Thu, 29 Feb 2024 08:45:04 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-antibody-drug-conjugates-guidance-industry