Scholar Rock, Inc. · 完整回复函 (BLA 761463)

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. FOOD & DRUG INISTRATION BLA 761463 COMPLETE RESPONSE Scholar Rock, Inc. Attention: Neda Aghajani Memar, PharmD Senior Director, Global Regulatory Affairs 301 Binney Street, 3ra Floor Cambridge, MA 02142 Dear Dr. Memar: Please re (b) (4) fer to your biologics license application (BLA) oe for SRK-015 (apitegromab-mstn) injection, for intravenous use. We have completed our review of this application and have determined that we cannot approve tl action be! his application in its present form. We have described our reasons for this low and, where possible, our recommendations to address these issues. FACILITY INSPECTIONS Fo lowing a CGMP inspection of oo oye) , listed in this application, FDA conveyed deficiencies to the representative of the facility. The facility should

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