http://www.fda.gov/ en 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. Thu, 16 May 2024 16:50:15 EDT FDA http://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Thu, 16 May 2024 15:36:02 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. Thu, 16 May 2024 09:35:51 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/enforcement-actions-cber/bimoteam-biologicsinternet-surveillanceother This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other. Wed, 15 May 2024 15:44:35 EDT FDA http://www.fda.gov/vaccines-blood-biologics/enforcement-actions-cber/bimoteam-biologicsinternet-surveillanceother 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. Wed, 15 May 2024 13:12:43 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue This is the draft guidance Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products Wed, 15 May 2024 10:21:40 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-human-allogeneic-cells-expanded-use-cell-based-medical-products This is the draft guidance Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products Wed, 15 May 2024 10:02:40 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-testing-human-allogeneic-cells-expanded-use-cell-based-medical-products http://www.fda.gov/news-events/fda-voices/protecting-and-advancing-health-women-through-policy-research-education-and-outreach Since its inception in 1994, OWH has been at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach. Wed, 15 May 2024 09:35:55 EDT FDA http://www.fda.gov/news-events/fda-voices/protecting-and-advancing-health-women-through-policy-research-education-and-outreach 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) Wed, 15 May 2024 06:44:29 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-may-9-2024-meeting-announcement-05092024 This is the main page for the Blood Products Advisory Committee May 9, 2024 Meeting Announcement and meeting materials. Tue, 14 May 2024 14:12:09 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/blood-products-advisory-committee-may-9-2024-meeting-announcement-05092024 http://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 14 May 2024 13:51:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024 http://www.fda.gov/advisory-committees/blood-products-advisory-committee/roster-blood-products-advisory-committee This is the Roster of the Blood Products Advisory Committee (BPAC). Tue, 14 May 2024 13:05:32 EDT FDA http://www.fda.gov/advisory-committees/blood-products-advisory-committee/roster-blood-products-advisory-committee http://www.fda.gov/advisory-committees/blood-products-advisory-committee/charter-blood-products-advisory-committee This is the Charter of the Blood Products Advisory Committee. Tue, 14 May 2024 12:38:23 EDT FDA http://www.fda.gov/advisory-committees/blood-products-advisory-committee/charter-blood-products-advisory-committee http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/washington-fertility-center-678931-04302024 Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Tue, 14 May 2024 09:20:09 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/washington-fertility-center-678931-04302024 http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more. Tue, 14 May 2024 09:19:35 EDT FDA http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/collaborations-and-partnerships CBER Research Collaborations and Partnerships Mon, 13 May 2024 16:39:52 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/collaborations-and-partnerships http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/about-cber-research Information about CBER’s research vision, CBER’s research facilities, CBER research funding Mon, 13 May 2024 16:38:25 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/about-cber-research http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/cbers-research-scientists CBER’s Research Projects and Offices information Mon, 13 May 2024 16:26:24 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/cbers-research-scientists http://www.fda.gov/vaccines-blood-biologics/science-research-biologics Listing of research programs conducted by CBER scientists and their published scientific articles classified according to the type of work being done: such as general biologics research, allergenics research, blood research, cellular & gene therapy research, tissue research, vaccines research Mon, 13 May 2024 16:12:12 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/tissue-advanced-therapies-research This page is about Tissue & Advanced Therapies Research Mon, 13 May 2024 15:40:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/tissue-advanced-therapies-research