Scholar Rock, Inc. · lettre de réponse complète (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 provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response. The facility’s satisfactory responses are dependent on FDA’s determination that the facility has come into compliance with CGMP and may require re-inspection of the facility. The deficiencies identified during the inspection may not be specific to your application. Therefore, you should coordinate with the facility for timely resolution. Your complete response should include the date(s) of the facility's response(s) to the FDA Form 483. Please refer to Compliance Program CP 7356.002 for guidance on post inspection activities. Following resolution of the CGMP ins

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