CBER Touts Performance, Contributions to Public Health in FY2015

Regulatory NewsRegulatory News | 17 December 2015 |  By 

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report.

Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA.

As in previous years, CBER met or exceeded the performance goals for product reviews established by the various User Fee Acts:

Standard & priority BLA/NDA reviews100% on time
Standard & priority Efficacy Supplements100% on time
MDUFA Decisions100% within 90 day target
Medical Countermeasures (MCM) Projects Funded22 "regulatory science projects on emerging infectious diseases, pandemic influenza, and other chemical, biological, radiological, and nuclear threat (CBRN) issues"


2 regulatory science projects awarded Ebola supplemental funding

2 regulatory science projects awarded challenge grant funding

CBER also had a relatively busy year for reviews, in FY2015 the center approved 13 new biological license applications (BLAs), four of which were new vaccines.

CBER Biological License Application (BLA) Approvals FY2015 (1 October 2014-30 September 2015)
TrumenbaFirst vaccine in the United States to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in individuals 10 through 25 years of age.
BexseroSecond vaccine licensed to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Gardasil 9Indicated for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV), five more HPV types than Gardasil (previously approved by the FDA). Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.
QuadracelActive immunization against diphtheria, tetanus, pertussis and poliomyelitis for use in children 4 through 6 years of age.
ObizurFor the treatment of bleeding episodes in adults with acquired hemophilia A.
INTERCEPT Blood System for PlateletsFirst system for reducing pathogens (e.g., HIV, Hepatitis B and C viruses, West Nile virus) in single-donor apheresis platelets.
AnthrasilTreatment for inhalation anthrax in combination with appropriate antibacterial drugs.
AnavipTreatment for management of adult and pediatric patients to neutralize rattlesnake venom.
MP Diagnostics HTLV Blot 2.4First FDA-licensed supplemental test for this virus in human serum or plasma; intended to confirm HTLV infection in blood donors and to differentiate between HTLV-I and HTLV-II following a positive result on an FDA-licensed HTLV-I/II blood donor screening test.
RaplixaTreatment to help control bleeding in adults from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical.
NuwiqIndicated in adults and children with Hemophilia A for:


On-demand treatment and control of bleeding episodes

Perioperative management of bleeding

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

IxinityIndicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.
Cobas TaqScreen MPX Test, version 2.0 Intended for use to screen for HIV RNA, HCV RNA, and HBV DNA in plasma specimens from human donors.


The report also emphasizes CBER's role in the response to the Ebola outbreak in West Africa.

During the reporting period, CBER says it mobilized its experts on the Vaccines and Related Biological Products Advisory Committee and organized a workshop with other government agencies intended to "inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola."

Additionally, CBER says it expedited the review of multiple investigational vaccines to treat Ebola, and lent its expertise to sponsors in pre-IND meetings for Ebola vaccine candidates.

On an international scale, CBER said it participated in 14 meetings with other regulatory authorities and provided expert advice at World Health Organization (WHO) consultations in its efforts to combat Ebola.



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