http://www.fda.gov/ en 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, 01 Aug 2023 15:57:43 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/vaccines-blood-biologics/vaccines/questions-about-vaccines Information on general and specific vaccines Tue, 01 Aug 2023 12:34:39 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/questions-about-vaccines 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, 01 Aug 2023 06:48:01 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/renatilabs-inc-646353-06012023 Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Mon, 31 Jul 2023 15:17:04 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/renatilabs-inc-646353-06012023 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 Jul 2023 14:47:47 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/octagam Product approval information is indicated for the treatment of chronicimmune purpura (ITP) in adults Mon, 31 Jul 2023 09:50:27 EDT FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/octagam http://www.fda.gov/news-events/press-announcements/fda-roundup-july-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 28 Jul 2023 16:31:14 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-july-28-2023 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. Fri, 28 Jul 2023 15:15:35 EDT FDA http://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents 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, 28 Jul 2023 14:02:56 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes http://www.fda.gov/vaccines-blood-biologics/lantidra Product information for LANTIDRA Fri, 28 Jul 2023 10:25:34 EDT FDA http://www.fda.gov/vaccines-blood-biologics/lantidra http://www.fda.gov/news-events/fda-newsroom/fda-voices Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco. Fri, 28 Jul 2023 09:46:46 EDT FDA http://www.fda.gov/news-events/fda-newsroom/fda-voices http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 27 Jul 2023 16:13:49 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood-lifesouth For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myelo Thu, 27 Jul 2023 12:25:17 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/hpc-cord-blood-lifesouth http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/2023-meeting-materials-cellular-tissue-and-gene-therapies-advisory-committee This is the main landing page for the CBER 2023 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). Thu, 27 Jul 2023 08:43:27 EDT FDA http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/2023-meeting-materials-cellular-tissue-and-gene-therapies-advisory-committee http://www.fda.gov/vaccines-blood-biologics/roctavian Product information for ROCTAVIAN Wed, 26 Jul 2023 13:45:45 EDT FDA http://www.fda.gov/vaccines-blood-biologics/roctavian http://www.fda.gov/consumers/consumer-updates/hiv-and-hepatitis-know-your-status-and-learn-about-fdas-role The U.S. Food and Drug Administration is working to reduce health disparities among people of different ethnic and racial groups. The agency's Office of Minority Health is now focusing efforts on educating people about HIV and hepatitis. Here's what to know about testing, treatment, and the FDA role Wed, 26 Jul 2023 10:35:44 EDT FDA http://www.fda.gov/consumers/consumer-updates/hiv-and-hepatitis-know-your-status-and-learn-about-fdas-role http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-status-biologics Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER Wed, 26 Jul 2023 09:06:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-status-biologics http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-d Contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER). Wed, 26 Jul 2023 09:04:30 EDT FDA http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-d http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-l-p Contains names, addresses, and other information gathered from inspections of clinical investigators (L-P) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER). Wed, 26 Jul 2023 09:03:43 EDT FDA http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-l-p http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-e-k Contains names, addresses, and other information gathered from inspections of clinical investigators (E-K) who have conducted studies with investigational new drugs or investigational devices reviewed by the Center for Biologics Evaluation and Research (CBER). Wed, 26 Jul 2023 09:03:06 EDT FDA http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/clinical-investigator-inspection-list-e-k