http://www.fda.gov/ en 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 Sep 2023 13:31:26 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics 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, 01 Sep 2023 08:16:12 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/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-modify-pharmaceutical-product-application-step-step-instructions This is the main page for How to Modify a CPP Application. Thu, 31 Aug 2023 14:19:39 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-modify-pharmaceutical-product-application-step-step-instructions http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-search-certificate-pharmaceutical-product-application-step-step This is the main page for How to Search for a CPP Application. Thu, 31 Aug 2023 14:16:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-search-certificate-pharmaceutical-product-application-step-step http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-how-enter-certificate-pharmaceutical-product-application This is the main page for How to Enter a Certificate of a Pharmaceutical Product (CPP) Application. Thu, 31 Aug 2023 14:13:59 EDT FDA http://www.fda.gov/vaccines-blood-biologics/exporting-cber-regulated-products/becats-external-user-guide-how-enter-certificate-pharmaceutical-product-application 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, 31 Aug 2023 09:36:54 EDT 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. Thu, 31 Aug 2023 09:36:32 EDT 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. Wed, 30 Aug 2023 16:33:05 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances http://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act Procedural Wed, 30 Aug 2023 09:29:16 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act http://www.fda.gov/news-events/press-announcements/fda-roundup-august-29-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 29 Aug 2023 15:06:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-29-2023 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, 29 Aug 2023 14:46:27 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, 29 Aug 2023 13:27:30 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/questions-about-vaccines http://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives. Tue, 29 Aug 2023 12:17:20 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. Tue, 29 Aug 2023 12:15:35 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions. Mon, 28 Aug 2023 17:48:23 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program http://www.fda.gov/vaccines-blood-biologics/cber-2023-orphan-approvals-new-blas CBER Orphan Approvals for 2023 Mon, 28 Aug 2023 17:35:52 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-2023-orphan-approvals-new-blas http://www.fda.gov/vaccines-blood-biologics/cber-2022-orphan-approvals-new-blas CBER Orphan Approvals for 2022 Mon, 28 Aug 2023 17:35:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-2022-orphan-approvals-new-blas http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices. Mon, 28 Aug 2023 14:58:50 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program-frequently-asked-questions CBER Rare Disease Program Frequently Asked Questions Mon, 28 Aug 2023 14:25:19 EDT FDA http://www.fda.gov/vaccines-blood-biologics/cber-rare-disease-program-frequently-asked-questions http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Mon, 28 Aug 2023 09:56:49 EDT FDA http://www.fda.gov/consumers/consumer-updates