FDA's Center for Biologics Evaluation and Research Issues Annul Report and New Directions

Main Category: Pharma Industry / Biotech Industry
Article Date: 01 May 2004 - 0:00 PDT


Today, FDA's Center for Biologics Evaluation and Research (CBER) issued its annual report that provides highlights from CBER's activities during Fiscal Year (FY) 2003 and introduces key initiatives for 2004.

CBER is responsible for addressing regulatory challenges related to a wide range of biologic products including blood, blood products, human tissue, cell and gene therapies, vaccines, and allergenic products.

Meeting these challenges successfully requires knowledge and utilization of scientific advances in areas such as proteomics, genomics and gene therapies, xenotransplantation, new vaccine technologies and delivery methods, and somatic cell and novel tissue therapies.

CBER continues to meet or exceed the higher performance goals in the Prescription Drug User Fee Act (PDUFA) III. In addition, CBER has demonstrated that it has the ability to provide timely review of device submissions, consistent with the Medical Device User Fee and Modernization Act (MDUFMA) goals.

The Agency's report to Congress on CBER's work during the first year of MDUFMA indicates that the device program in Biologics has already improved its timeliness and responsiveness.

In the coming year, CBER expects to make significant progress on a number of important initiatives that support the goals of FDA's new strategic plan, including efficient risk management, improving healthcare through better information, improving patient and consumer safety, protecting America from terrorism, and smarter regulation through a stronger workforce.

Examples of important CBER initiatives include:

-- Improving product review through the new "Review Template Initiative" to institutionalize best review practices and improve the consistency, quality, ease and efficiency of review;

-- Implementation of a Tissue Safety System, including finalization of FDA's regulatory framework for tissue safety, continuing outreach to the tissue industry, and development of an interdisciplinary Tissue Safety Team;

-- Formation of a Policy Coordinating Council, to address cross cutting Center issues and better assure the development of important Center-wide policies;

-- Development of a Counterterrorism Product Safety and Integrity Plan to put measures in place to help better assure the availability and safety of needed products in the event of a terrorist attack;

-- Development of a management training initiative, to help provide CBER managers and leaders with the updated tools they need to make the best use of available human and material resources;

-- Implementation of a formal reviewer training program in fundamentals of risk management, assessment and communication;

-- Enhancing external interactions by:

1. Increasing opportunities for input to and transparency of CBER programs, including opportunities for Advisory Committee and stakeholder input into CBER programs.

2. Fostering career development programs for CBER Staff, such as continuing clinical and teaching activities for medical personnel, a program of blood bank rotations for blood product and device reviewers, and programs such as sabbaticals and interagency agreements (IAGs).

Developing a strategic approach to international programs that will maximize public health benefits in areas such as emerging infectious diseases and global vaccine development.

CBER's annual report is available at http://www.fda.gov/cber/inside/annrpt.htm

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