BRIEF—FDA/CBER 2017 Report from the director

The US Center for Biologics Evaluation and Research (CBER) worked diligently during Fiscal Year 2017 to fulfill its core mission: ensuring that safe and effective biologic products and related devices are available to the public, said Dr Peter Marks, director of the Center, adding: “We are particularly proud to have approved several therapeutic ‘firsts’ that represent significant achievements in fulfilling our mission.”

Kymriah, the first gene therapy in the US, which is approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse; MACI, the first FDA-approved product for repairing knee cartilage defects in adults that is grown from cells on scaffolds using healthy cartilage tissue from the patient’s own knee; Odactra, the first allergenic extract to be administered under the tongue for the treatment of house dust mite-induced nasal inflammation; and Haegarda, the first subcutaneous preventive treatment option for hereditary angioedema (HAE), which enables easier at-home self-injection by the patient or caregiver, to prevent HAE attacks in adolescent and adult patients.

In addition, the Center played an important role in protecting and promoting the public health against emerging infectious diseases, such as Zika and Ebola. During FY 2017, CBER completed expedited reviews of seven Investigational New Drug applications ( INDs) for Zika vaccines, and CBER continues to advise the US Department of Health and Human Services (HHS) and international regulatory partners on Zika virus vaccine development. The Center also continued to provide strategic direction to national regulatory authorities addressing safety and efficacy concerns related to Ebola virus vaccines in development. In addition, CBER oversaw the implementation of nationwide blood donor screening for Zika virus using two investigational donor screening nucleic acid tests, and subsequently licensed the cobas Zika test—the first test intended to detect Zika virus in blood donations and living organ donors.

The report below highlights these and other CBER accomplishments of FY 2017. The work performed contributed not only to the core mission of the FDA, but also to national and international public health, and to global preparedness for future public health challenges.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm591387.htm?utm_campaign=What%27sNew2017-01-08&utm_medium=email&utm_source=Eloqua