http://www.fda.gov/ en http://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/roster-allergenic-products-advisory-committee As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. Tue, 02 Jan 2024 08:49:52 EST FDA http://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/roster-allergenic-products-advisory-committee 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. Tue, 02 Jan 2024 07:39:34 EST FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Thu, 28 Dec 2023 16:08:27 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. Thu, 28 Dec 2023 09:13:56 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances This page contains a listing of cellular and gene therapy guidances. Thu, 28 Dec 2023 09:12:42 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances http://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products This is the Draft Guidance for Industry, Potency Assurance for Cellular and Gene Therapy Products Thu, 28 Dec 2023 09:04:27 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/labeling-and-promotion-guidances This page lists Labeling and Promotion Guidance documents. Wed, 27 Dec 2023 15:48:08 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/labeling-and-promotion-guidances http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-11062024 This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. Wed, 27 Dec 2023 11:44:02 EST FDA http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-11062024 http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-06182024 This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. Wed, 27 Dec 2023 11:44:01 EST FDA http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-06182024 http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-03202024 This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. Wed, 27 Dec 2023 11:44:01 EST FDA http://www.fda.gov/about-fda/office-bioresearch-monitoring-operations-obimo/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference-03202024 http://www.fda.gov/science-research/real-world-evidence/center-biologics-evaluation-and-research-center-drug-evaluation-and-research-real-world-evidence Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research Real-World Evidence Wed, 27 Dec 2023 11:01:57 EST FDA http://www.fda.gov/science-research/real-world-evidence/center-biologics-evaluation-and-research-center-drug-evaluation-and-research-real-world-evidence http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta-axicabtagene-ciloleucel YESCARTA is a treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Wed, 27 Dec 2023 10:37:28 EST FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta-axicabtagene-ciloleucel 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, 26 Dec 2023 14:40:45 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances This page lists Clinical Guidance documents. Tue, 26 Dec 2023 10:58:02 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances http://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products Guidance for Industry Fri, 22 Dec 2023 09:08:14 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products http://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data Data Standards for Drug and Biological Product Submissions Containing Real-World Data Fri, 22 Dec 2023 09:06:47 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances This page lists Administrative Guidance documents. Fri, 22 Dec 2023 08:28:30 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti For the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody Thu, 21 Dec 2023 16:20:14 EST FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti http://www.fda.gov/vaccines-blood-biologics/vaccines/hiberix HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Thu, 21 Dec 2023 15:17:26 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/hiberix http://www.fda.gov/news-events/fda-voices/realizing-promise-real-world-evidence Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area. Thu, 21 Dec 2023 10:58:40 EST FDA http://www.fda.gov/news-events/fda-voices/realizing-promise-real-world-evidence