ELA elimination under FDA proposal would permit single license holder for multiple facilities.
FDA WILL ALLOW BIOLOGICS LICENSE HOLDER TO ASSUME RESPONSIBILITY for all establishments "engaged in significant production steps," eliminating the requirement that each biological manufacturing facility obtain a separate license, according to a proposed rule scheduled for publication in the Jan. 29 Federal Register. The proposal, which eliminates the ELA requirement for "well-characterized biologics," expands the definition of "manufacturer" to include "an applicant for a license for a well-characterized biotechnology product."
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