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Regulatory News | 17 October 2016 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released an interim strategic plan for FY 2017 through 2019, offering the same six overarching goals the center initially developed in 2011, though with updated strategies to achieve them.
The center’s “inherently interrelated” five overarching program goals and final cross-cutting goal include:
Goal 1: Increase the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases.
Goal 2: Improve global public health through international collaboration including research and information sharing.
Goal 3: Utilize advances in science and technology to facilitate development of safe and effective biological products.
Goal 4: Ensure the safety of biological products.
Goal 5: Advance regulatory science and research.
Goal 6: Manage for organizational excellence and accountability.
In terms of the goal on biological preparedness, CBER focuses its efforts not only on regulatory support to industry in developing sustainable flu vaccine production capacity but also trying to develop and evaluate new preclinical methods to screen novel adjuvants for their potential adverse effects prior to starting clinical trials.
“Availability of new adjuvants may enhance the immune response to the influenza vaccine antigens, and may also result in the increased availability of a vaccine during a pandemic event,” CBER says, also noting its work on medical countermeasures and infectious agents that can compromise product safety and availability, whether due to the spread of disease vectors (e.g. Zika, dengue, babesiosis), travel and immigration (e.g. malaria, Leishmania), terrorism (e.g. anthrax) or previously rare or unknown infectious agents (e.g., Ebola virus, vCJD, SARS-CoV, Chikungunya virus, Zika virus, Q-fever agent).
As for international collaborations, CBER notes new paradigms emerging in the form of nongovernmental organizations (NGOs) and product development partnerships to address unmet product development needs, with unique regulatory pathways and the inevitable regulatory science challenges.
The center is also looking to advance efforts to develop and improve sharing of reference materials and biological standards with the international scientific community and foreign regulatory bodies, to lay the groundwork for accreditation to ISO Guide 34 standard for reference material manufacturers, to continue to collaborate on global health issues such as pandemic influenza, Ebola virus, Zika virus, Dengue virus, Babesia, and HIV, and to serve as a PAHO/WHO Collaborating Center for Biological Standardization and as an Essential Regulatory Laboratory within WHO’s influenza vaccine network, serve as a WHO Collaborating Center for biologics, including hematologic products and in vitro diagnostics, and collaborate with the WHO Prequalification Team – Diagnostics Working Group on dossier instructions and guidance for HIV diagnostic assays.
CBER Interim Strategic Plan 2017-2019
Tags: CBER strategic plan, pandemic preparedness, FDA and international partners