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ELA |
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? References in periodicals archive |
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Regeneron manufactures the intermediate at its Rensselaer, New York facility under an FDA-approved supplement to Merck's Establishment License Application. A complete review letter has been received for the THYMOGLOBULIN PLA, and FDA action on THYMOGLOBULIN's Establishment License Application (ELA) is expected soon. The regulatory approval process for a biological product involves the submission of an Establishment License Application (ELA) for the manufacturing process and facility, while the product characteristics, non-clinical and clinical data, are submitted in a PLA. |
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