http://www.fda.gov/ en http://www.fda.gov/vaccines-blood-biologics/vaccines/varivax-refrigerated-and-frozen-formulations Product approval information for Varicella Virus Vaccine Live also known as Varivax. Wed, 01 Mar 2023 17:28:51 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/varivax-refrigerated-and-frozen-formulations 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 section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. Wed, 01 Mar 2023 16:26:02 EST 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/vaccines/measles-mumps-and-rubella-virus-vaccine-live Product approval information for the Measles, Mumps, and Rubella Virus Vaccine, Live also known as M-M-R II. Wed, 01 Mar 2023 13:22:55 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/measles-mumps-and-rubella-virus-vaccine-live http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8200-investigational-new-drugs-inds This is the SOPP Section 8200: Investigational New Drugs (INDs) main page. Wed, 01 Mar 2023 09:49:35 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8200-investigational-new-drugs-inds http://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments Fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family. Wed, 01 Mar 2023 08:53:03 EST FDA http://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-cber-regulated-products To facilitate FDA’s transition to a fully automated electronic submission and review process, many of the FDA electronic submission standards are now mandatory Wed, 01 Mar 2023 08:38:22 EST FDA http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-cber-regulated-products http://www.fda.gov/vaccines-blood-biologics/vaccines/flucelvax-quadrivalent For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Tue, 28 Feb 2023 23:07:59 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/flucelvax-quadrivalent http://www.fda.gov/vaccines-blood-biologics/vaccines/adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Tue, 28 Feb 2023 16:18:04 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/adacel 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, 28 Feb 2023 14:41:00 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/roster-cellular-tissue-and-gene-therapies-advisory-committee This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee. Tue, 28 Feb 2023 14:27:38 EST FDA http://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/roster-cellular-tissue-and-gene-therapies-advisory-committee http://www.fda.gov/vaccines-blood-biologics/vaccines/pentacel For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday). Tue, 28 Feb 2023 14:22:39 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/pentacel http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-procedures-sopps These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates. These SOPPs are organized by area of activity. Tue, 28 Feb 2023 14:20:15 EST FDA http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-procedures-sopps http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-9150-office-therapeutic-products This is the SOPP Section 9150: Office of Therapeutic Products. Tue, 28 Feb 2023 14:17:11 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-9150-office-therapeutic-products http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee This is the Roster of the Vaccines and Related Biological Products Advisory Committee Tue, 28 Feb 2023 14:17:04 EST FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/methods-and-approaches-capturing-post-approval-safety-and-efficacy-data-cell-and-gene-therapy Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products. Tue, 28 Feb 2023 11:28:12 EST FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/methods-and-approaches-capturing-post-approval-safety-and-efficacy-data-cell-and-gene-therapy http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/obizur Product approval information is indicated for the treatment of bleeding episodes in adults with acquired hemophilia A. Tue, 28 Feb 2023 11:00:07 EST FDA http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/obizur http://www.fda.gov/vaccines-blood-biologics/vaccines/menactra Product approval information for the Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine also known as Menactra Tue, 28 Feb 2023 10:06:33 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/menactra http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications This is the SOPP Section 8400: Marketing Applications main page. Tue, 28 Feb 2023 09:30:49 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-28-march-1-2023-meeting This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials. Tue, 28 Feb 2023 08:15:25 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-28-march-1-2023-meeting http://www.fda.gov/vaccines-blood-biologics/vaccines/kinrix Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist. Tue, 28 Feb 2023 07:28:57 EST FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/kinrix