Innovation and Regulatory Science
CBER plays a critical role in the development of biological products that are at the cutting edge of 21st century medicine.
CBER Research Collaborations
Accurate and simultaneous identification of influenza viruses High-dose influenza vaccine is significantly more effective than standard dose in elderly Intranasal administration of tuberculosis vaccine studied in mice FDA study identifies occurrence and risk factors for TRALI, a post-transfusion respiratory complication, among the U.S. elderly during 2007 through 2011 FDA study identifies occurrence and potential risk factors for postransfusion purpura (PTP) in elderly patients FDA scientists investigate the impact of the adjuvant MF59 combined with H5 avian influenza vaccine on immune response in a prime-boost vaccination strategy Candidate universal influenza A vaccine reduces virus transmission in mice FDA develops alternative assay that could speed availability of influenza vaccines in the event of a future pandemic FDA study findings could facilitate development of safe artificial blood Maternal and Neonatal Vaccination Protects Newborn Baboons from Pertussis Infection Working towards keeping stored platelets free of bacteria New method could speed potency testing of influenza vaccines FDA scientists discover how to shield gene therapy vectors against attack by the immune system FDA-Led Study Describes Mechanism Potentially Responsible for Respiratory Side Effect Associated with a Pig Influenza Vaccine Antibodies against common target on different influenza viruses suggest strategy for development of broadly-protective influenza vaccines Anthrax toxin reduces level of a key protein that keeps lining of blood vessels intact Potential “universal” influenza vaccine tested at FDA A mouse model demonstrates a link between transfused UVB irradiated platelets and acute lung injury FDA study reinforces no safety concerns from residual formaldehyde in some infant vaccines[ARCHIVED] FDA develops simple and rapid poliovirus test to speed evaluation of vaccines and support global polio eradication campaign[ARCHIVED] Sensitive test for malaria protein could help FDA better evaluate malaria vaccines and give public health workers a new tool for tracking outbreaks Immune system enzyme is key to optimal antibody responses against influenza virus An Experimental vaccine for leishmaniasis that stimulates dog’s immune system might also prevent spread of the parasite to humans Improved Characterization of Bone Marrow Stromal Stem Cells Could Support Their Use as Safe and Effective Therapies Babesiosis, a Malaria-like Disease, May Be Rising Among Elderly in U.S[ARCHIVED] Evolving Data Mining System is Designed to Speed Identification of Adverse Events Following Vaccinations[ARCHIVED] FDA Study Suggests Critical Potential Role of Individual Bacteria in Spreading Anthrax Through Body Firefly Chemistry Used to Evaluate Tuberculosis Vaccines Reducing Medical Complications Caused by Transfusion with Blood Stored for Long Periods: A Study in Guinea Pig Model[ARCHIVED] Age and Gender Differences Seen in Immune System Response to the 2009 H1N1 Pandemic Influenza Virus Discovery of Hepatitis C Blocking Antibodies Suggests Strategies for Improving Treatment and Prevention Keeping Platelets Safe: The Potential Role of Antimicrobial Peptides Universal Influenza Vaccine against H5N1, H3N2, and H1N1 Shown Effective in Pre-Clinical Trials Proof-of-concept Dual Vaccine against both Smallpox and Anthrax Adjuvant Ramps Up Pandemic Flu Vaccines Innovative Strategy Could Speed Approval of Influenza Vaccines FDA’s Contributions to Advancing New Technologies for Developing Safe and Effective Influenza Vaccines(PDF - 52KB) Synonymous (â€œSilentâ€�) Mutations in Health, Disease, and Personalized Medicine: Review[ARCHIVED] Antibodies From Humans Receiving Investigational Influenza Vaccine Are Effective Against H5N1 (Avian Influenza) and Might Protect Against a Variety of These Viruses Outbreaks of Mumps Apparently Not Caused by New Viruses That Evade Existing Vaccine Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants â€œSwine Fluâ€� Vaccine of 1976 Protected Older Adults from the 2009 H1N1 Pandemic Virus[ARCHIVED] Mutation is enabling some influenza viruses to evade neutralization by previously broadly-active antibodies. Protecting the immunocompromised patient by modeling a potentially fatal smallpox vaccine side effect Novel insurance claims study shows some antibody-containing products pose increased risk of potentially fatal blood clots[ARCHIVED] DNA-like Probes (Aptamers) Help Detect Subtle Changes in Three-Dimensional Structure of Therapeutic Proteins The Global Public Health Concern of Leishmaniasis: FDA Scientists Play a Major Role in Development of a Candidate Vaccine to Protect Populations and Blood Supplies FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus Developing Gene Therapy for Cancers Using Virus Vectors Supporting the Development of Mesenchymal Stem Cells as Medical Therapies
Occurrence & risk factors for potentially fatal bleeding disorder called posttransfusion purpura (PTP) among the U.S. elderly patients(PDF - 259KB) Transfusion-Related Acute Lung Injury (TRALI) occurrence and risk factors among the U.S. elderly(PDF - 320KB)
- Successful Development of Baboon Model of Pertussis is Starting Point for Understanding and Preventing this Resurgent Disease (PDF - 17.5MB)
FDA describes mechanism potentially responsible for respiratory side effect associated with influenza vaccine(PDF - 6.1MB) FDA discovery that Ad5 vector uses coagulation factor X to block complement proteins has major implications for gene therapy(PDF - 182KB) Expanded and improved approach to identifying surface protein markers could support development of therapies with human bone marrow multipotent stromal cells(PDF - 262KB) Individual bacteria could play critical role in spread of anthrax through body(PDF - 901KB) Decreased response to vaccines in older adults is linked to waning level of B-cell enzyme called AID(PDF - 36.6MB) Babesiosis, a malaria-like infection, might be Rising among Elderly in the United States(PDF - 6.5MB) Leishmaniasis Vaccine Development Aimed at Slowing Global Spread of Disease(PDF - 45.3MB) Characterization of intracellular ATP Iuminescence assay for rapid evaluation of tuberculosis vaccine (Mycobacterium bovis BCG)(PDF - 11.7MB) An alternative method for preparation of pandemic influenza strain-specific antibody for vaccine potency determination(PDF - 1.2MB) A Candidate Universal Vaccine for Control of Rapidly Emerging, Highly Virulent Influenza Viruses(PDF - 4.3MB) CBER Receives Accreditation for Laboratory Testing of Influenza Vaccines and Evaluation of Blood Donor Screening Kits(PDF - 194KB) A Potential Strategy for Preventing Complications of Hemolytic Diseases and Toxicity of Hemoglobin-Based Oxygen(PDF - 358KB) Keeping Platelets Safe: Potential Role of Antimicrobial Peptides(PDF - 195KB) Identifying Faster Sterility Tests for Biological Products(PDF - 185KB) Developing the "Ultimate Tool" to Ensure Live Viral Vaccine Safety(PDF - 401KB) A Potential Strategy for Successful Treatment and Prevention of Hepatitis C Infection(PDF - 1.8MB) Age and Gender Difference in the Immune System Response to the 2009 H1N1 Pandemic Influenza Virus(PDF - 15.6MB) Advancing Regulatory Science: CBER-Produced Botulinum Toxoids Support Development of Improved Standards for Testing Botulinum Antitoxin Products(PDF - 234KB) CBER Science Supports Vaccine Development and Assays of Vaccine Safety and Efficacy(PDF - 245KB) Insight into How Carbon Nanotubes Cause a Thrombus: Activation of Platelets Through “Store-Operated” Calcium Entry(PDF - 806KB) Evidence for a Link between an Immune Globulin Product and Thrombosis(PDF - 216KB)