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The Center for Biologics Evaluation & Research (CBER) published the "Direct Recall Classification Program (Bllod and Plasma) in November. Direct Recall Classification (DRC) refers to the classification of blood and plasma recalls directly by personnel in the Center for Biologics Evaluation and Research in lieu of more traditional methods that require additional hours of work by personnel located in each FDA district office. DRC was designed to utilize current information technology to streamline recall classification of biological products. Through the use of an electronic interface between two existing agency databases, the time and resources previously needed to review and classify recalls of biological products have been greatly reduced. The effects of the DRC will be: - If you are a consumer, DRC means that recalls of biological products are posted in the public domain in a more timely manner.
- If you are member of the biologics industry, you will be able to provide information to FDA regarding a recall you are conducting of biological products electronically, thus reducing the burden of copying manual records and sending them to an FDA district office. DRC also facilitates communication with the agency to answer questions or to gather more information regarding a recall.
- For the agency, DRC has decreased the amount of time previously used by the district office and CBER to gather, evaluate, review and classify a firm’s recall action. The average amount of time from learning of a firm’s recall action to classification of the recall has decreased from years to weeks and through the use of DRC, continues to decrease. CBER personnel have consistently exceeded performance measures for classification of recalls though the use of DRC (FDA-TRACK1).
- For the agency as well as for the public, DRC decreased the resources needed to classify and publish recalls, and allows the reallocation of resources to other agency priorities related to protection of the public health.
More information is also available in the Direct Recall Classification Program (Blood and Plasma). Author
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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