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April 01, 2006 (Vol. 26, No. 7)

Characterization of Biologicals Is Advancing

Globally Harmonized Regulatory Approach Is Needed to Move Forward Expeditiously

  • The concept of well-characterized biologicals originated with the FDA Center for Biologics Evaluation and Research (CBER), which first employed the term in 1996. Prior to 1996, CBER required both a Product License Agreement (PLA) and an Establishment License Agreement (ELA) for product approval. The ELA was specific to the ...

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