Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/ en 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. Mon, 17 Jun 2024 17:25:56 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents Vaccines Licensed for Use in the United States http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states The product name and trade name of vaccines licensed for use in the United States. Mon, 17 Jun 2024 17:22:32 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states 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 Mon, 17 Jun 2024 17:13:19 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Expanded Access (Compassionate Use) Submission Data http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data Expanded Access (Compassionate Use) Submission Data Mon, 17 Jun 2024 12:00:13 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data COVID-19 Vaccines http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Fri, 14 Jun 2024 16:43:12 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines Standards Development for Regenerative Medicine Therapies http://www.fda.gov/vaccines-blood-biologics/standards-development-regenerative-medicine-therapies Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated regenerative medicine advanced therapies. Fri, 14 Jun 2024 16:01:47 EDT FDA http://www.fda.gov/vaccines-blood-biologics/standards-development-regenerative-medicine-therapies COVID-19 Vaccines for 2023-2024 http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines-2023-2024 For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall of 2023, the FDA advised manufacturers to provide a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant targeting XBB.1.5. Fri, 14 Jun 2024 15:54:38 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines-2023-2024 FDA Roundup: June 14, 2024 http://www.fda.gov/news-events/press-announcements/fda-roundup-june-14-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 14 Jun 2024 15:54:06 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-14-2024 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 Fri, 14 Jun 2024 14:52:47 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes 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. Fri, 14 Jun 2024 00:00:10 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber YESCARTA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. Thu, 13 Jun 2024 21:20:29 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta TECARTUS http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Thu, 13 Jun 2024 21:12:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024 http://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024 FDA&#039;s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 5, 2024, to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2024. <br /> <br /> Thu, 13 Jun 2024 16:03:52 EDT FDA http://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024 Advisory Committees Give FDA Critical Advice and the Public a Voice 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. Thu, 13 Jun 2024 15:05:10 EDT FDA http://www.fda.gov/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice LYFGENIA http://www.fda.gov/vaccines-blood-biologics/lyfgenia LYFGENIA is indicated for treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). Thu, 13 Jun 2024 13:56:11 EDT FDA http://www.fda.gov/vaccines-blood-biologics/lyfgenia Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-assessment-donor-suitability-and-blood-and-blood-product-safety-cases-possible Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax, CBER, biologics, guidance, industry, donor, blood, anthrax, safety, screening Thu, 13 Jun 2024 12:13:56 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-assessment-donor-suitability-and-blood-and-blood-product-safety-cases-possible Validation of Procedures for Processing of Human Tissues Intended for Transplantation http://www.fda.gov/regulatory-information/search-fda-guidance-documents/validation-procedures-processing-human-tissues-intended-transplantation Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation, CBER, Biologics, Processing of Human Tissues, Transplantation Thu, 13 Jun 2024 11:08:19 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/validation-procedures-processing-human-tissues-intended-transplantation Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-deferral-donors-and-quarantine-and-retrieval-blood-and-blood-products-recent Guidance for Industry, Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients, CBER, Biologics Thu, 13 Jun 2024 11:05:39 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-deferral-donors-and-quarantine-and-retrieval-blood-and-blood-products-recent Remarks by Dr. Califf and Dr. Bumpus at the FDA Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees - 06/13/2024 http://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-califf-and-dr-bumpus-fda-public-meeting-optimizing-fdas-use-and-processes-advisory Remarks by Robert M. Califf, M.D.<br /> Commissioner of Food and Drugs<br /> Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees<br /> June 13, 2024<br /> White Oak, MD Thu, 13 Jun 2024 10:56:44 EDT FDA http://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-califf-and-dr-bumpus-fda-public-meeting-optimizing-fdas-use-and-processes-advisory Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires http://www.fda.gov/regulatory-information/search-fda-guidance-documents/streamlining-donor-interview-process-recommendations-self-administered-questionnaires Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires, CBER, biologics, guidance, industry, blood, donor, questionnaire Thu, 13 Jun 2024 09:57:34 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/streamlining-donor-interview-process-recommendations-self-administered-questionnaires