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ELA elimination final rule drops "well characterized" definition; FDA expands list of eligible biologics.

Executive Summary

FDA BROADENS LIST OF NON-ELA BIOLOGICAL PRODUCT CATEGORIES in a final rule eliminating the requirement for establishment licensing applications for certain biologics published in the Federal Register May 14. The rule eliminates ELA requirements for therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, monoclonal antibody products for in vivo use and therapeutic recombinant DNA-derived products.

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