- by FDAThis is the SOPP Section 8200: Investigational New Drugs (INDs) main page.
- by FDACOMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
- by FDALatest news from the Center for Biologics Evaluation and Research
- by FDAAntimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.
- by FDACBER 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.
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- by FDAThis page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.
- by FDAPREA 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
- by FDAFDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.
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- by FDAInformation on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.
- by FDAThis public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases.
- by FDAThis page lists Recently Issued CBER and Cross-Center Guidance Documents.
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- by FDAInformation about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.
- by FDAPfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Authorized For Individuals 6 Months through 11 Years of Age
- by FDAThis page lists Biosimilars Guidance documents.
- by FDAThis page lists Labeling and Promotion Guidance documents.
- by FDAThe U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.