Regeneron announced that the U.S. Food and Drug Administration issued a complete response letter, or CRL, regarding the Chemistry, Manufacturing and Controls Prior-Approval Supplement for the EYLEA pre-filled syringe. The CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the EYLEA pre-filled syringe in approximately 30 patients. Regeneron expects to compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the EYLEA pre-filled syringe.
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