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CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development

Oct 4th, 2013

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Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products.

CBER Office of Compliance (OC) Director Mary Malarkey emphasized the significance of CBER’s soon-to-be-launched Biologics Export Certification Application and Tracking System (BECATS) in providing an update on her office’s initiatives at the annual PDA/FDA conference in Washington, D.C. in mid-September.

Firms exporting products from the US are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA – a document prepared by the agency containing information about a product’s regulatory or marketing status.

BECATS aims to streamline the process for applying for and obtaining export certificates for CBER-regulated products using an all-electronic Internet-based form of submission. Malarkey noted that the first phase will address certificates for foreign governments, which accounts for about half of CBER’s certificate workload.  She anticipates a roll-out “very shortly.”

Other current CBER OC focal points, Malarkey said, include: ● the implementation of FDASIA ● flu vaccine and pandemic preparedness ● an electronic lot release system ● a direct recall classification system ● risk-based efforts to focus inspection and compliance resources ● updates to its website, and ● the center’s upcoming move to FDA’s White Oak campus.  She also commented on the “large inventory” of facilities that CBER oversees and the compliance actions the center has been taking recently.

[The story continues for subscribers beginning on page 2.  Included are more insights on the current CBER initiatives from Malarkey and from the center’s deputy director.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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