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ĚŽƐĞ ĂŶĚ ƌĂƚĞ ŽĨ ŝŶĨƵƐŝŽŶ ŽĨ ƚŚĞ ƉƌŽƉŽƐĞĚ ƉƌŽĚƵĐƚ ĂƌĞĚĞƉĞŶĚĞŶƚ ŽŶ ƚŚĞ ŝŶĚŝǀŝĚƵĂů ŶĞĞĚƐ ŽĨ ƚŚĞ ƉĂƚŝĞŶƚ͗\u003Cbr>&Žƌ ƚƌĞĂƚŵĞŶƚ ŽĨ ŚLJƉŽƉŚŽƐƉŚĂƚĞŵŝĂ͗\u003Cbr>􀀄ĚƵůƚƐ͗ dŚĞ ŵĂdžŝŵƵŵ ĚŽƐĂŐĞ ŝƐ ϰϱ ŵŵŽů ƉŚŽƐƉŚŽƌƵƐ ƉĞƌ ĚĂLJ͘\u003Cbr>􀀘ŽƐĂŐĞ ŵĂLJ ďĞ ĚĞƚĞƌŵŝŶĞĚ ďĂƐĞĚ ƉĞƌ ŬŐ ďŽĚLJ ǁĞŝŐŚƚ Žƌ Ă ĨŝdžĞĚĚŽƐĞ ƌĞŐŝŵĞŶ͘ dŚĞ ĨŽůůŽǁŝŶŐ ƌĞĐŽŵŵĞŶĚĞĚ ĚŽƐĂŐĞƐ ĂƌĞ ƐƵŝƚĂďůĞ ĨŽƌŵŽƐƚ ƉĂƚŝĞŶƚƐ͗ ƉŚŽƐƉŚŽƌƵƐ Ϭ͘ϭϲ ŵŵŽůͬŬŐ ƚŽ Ϭ͘ϲϰ ŵŵŽůͬŬŐ ;Žƌ\u003Cbr>(b) (4) \u003Cbr> ,ŽǁĞǀĞƌ͕ ďĂƐĞĚ ŽŶ ĐůŝŶŝĐĂů ƌĞƋƵŝƌĞŵĞŶƚƐ͕ƐŽŵĞ ƉĂƚŝĞŶƚƐ ŵĂLJ ƌĞƋƵŝƌĞ ŚŝŐŚĞƌ Žƌ ůŽǁĞƌ ĚŽƐĂŐĞƐ͘\u003Cbr>\u003Cbr>(b) (4) |\n\nŝ  \nsĞƌƐŝŽŶ ĚĂƚĞ͗ KĐƚŽďĞƌ ϭϮ͕ ϮϬϭϴ  \n\n| 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚ ĚŽƐŝŶŐƌĞŐŝŵĞŶ;ĐŽŶƚŝŶƵĞĚͿ | (b) (4) |\n| --- | --- |\n| 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚŝŶĚŝĐĂƚŝŽŶ;ƐͿͬƉŽƉƵůĂƚŝŽŶ;ƐͿ | /Ŷ ĂĚƵůƚƐ ĂŶĚ ĂĚŽůĞƐĐĞŶƚ ƉĂƚŝĞŶƚƐ ϭϮ ƚŽ фϭϴ LJĞĂƌƐ ŽĨ ĂŐĞ͗\u003Cbr>x ĂƐ Ă ƐŽƵƌĐĞ ŽĨ ƉŚŽƐƉŚŽƌƵƐ͕ ĨŽƌ ĂĚĚŝƚŝŽŶ ƚŽ ůĂƌŐĞ ǀŽůƵŵĞŝŶƚƌĂǀĞŶŽƵƐ ĨůƵŝĚƐ͕ ƚŽ ƉƌĞǀĞŶƚ Žƌ ĐŽƌƌĞĐƚ ŚLJƉŽƉŚŽƐƉŚĂƚĞŵŝĂŝŶ ƉĂƚŝĞŶƚƐ ǁŝƚŚ ƌĞƐƚƌŝĐƚĞĚ Žƌ ŶŽ ŽƌĂů ŝŶƚĂŬĞ͘\u003Cbr>x ĂŶ ĂĚĚŝƚŝǀĞ ĨŽƌ ƉƌĞƉĂƌŝŶŐ ƐƉĞĐŝĨŝĐ ƉĂƌĞŶƚĞƌĂů ĨůƵŝĚ ĨŽƌŵƵůĂƐǁŚĞŶ ƚŚĞ ŶĞĞĚƐ ŽĨ ƚŚĞ ƉĂƚŝĞŶƚ ĐĂŶŶŽƚ ďĞ ŵĞƚ ďLJ ƐƚĂŶĚĂƌĚĞůĞĐƚƌŽůLJƚĞ Žƌ ŶƵƚƌŝĞŶƚ ƐŽůƵƚŝŽŶƐ͘ |\n| 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚ^EKD􀀜􀀘 􀀒d ŝŶĚŝĐĂƚŝŽŶĚŝƐĞĂƐĞ ƚĞƌŵ ĨŽƌ ĞĂĐŚƉƌŽƉŽƐĞĚ ŝŶĚŝĐĂƚŝŽŶ |  |\n| ZĞĐŽŵŵĞŶĚĂƚŝŽŶ ŽŶƌĞŐƵůĂƚŽƌLJ ĂĐƚŝŽŶ | 􀀄ƉƉƌŽǀĂů ĨŽƌ ďŽƚŚ ƉŚŽƐƉŚŽƌƵƐ ƌĞƉůĂĐĞŵĞŶƚ ŝŶ ŝŶƚƌĂǀĞŶŽƵƐ ĨůƵŝĚƐ ĂŶĚŝŶ ƚŽƚĂů ƉĂƌĞŶƚĞƌĂů ŶƵƚƌŝƚŝŽŶ |\n| ZĞĐŽŵŵĞŶĚĞĚ\u003Cbr>ŝŶĚŝĐĂƚŝŽŶ;ƐͿͬƉŽƉƵůĂƚŝŽŶ;ƐͿ;ŝĨ ĂƉƉůŝĐĂďůĞͿ | WKd􀀄^^/hD W,K^W,􀀄d􀀜^ /E:􀀜􀀒d/KE ŝƐ Ă ƉŚŽƐƉŚŽƌƵƐ ƌĞƉůĂĐĞŵĞŶƚƉƌŽĚƵĐƚ ŝŶĚŝĐĂƚĞĚ ĂƐ Ă ƐŽƵƌĐĞ ŽĨ ƉŚŽƐƉŚŽƌƵƐ͗\u003Cbr>x ŝŶ ĂĚƵůƚƐ ĂŶĚ ƉĞĚŝĂƚƌŝĐ ƉĂƚŝĞŶƚƐ ϭϮ LJĞĂƌƐ ŽĨ ĂŐĞ ĂŶĚ ŽůĚĞƌ͗ ŝŶŝŶƚƌĂǀĞŶŽƵƐ ĨůƵŝĚƐ ƚŽ ĐŽƌƌĞĐƚ ŚLJƉŽƉŚŽƐƉŚĂƚĞŵŝĂ ǁŚĞŶ ŽƌĂů ŽƌĞŶƚĞƌĂů ƌĞƉůĂĐĞŵĞŶƚ ŝƐ ŶŽƚ ƉŽƐƐŝďůĞ͕ ŝŶƐƵĨĨŝĐŝĞŶƚ ŽƌĐŽŶƚƌĂŝŶĚŝĐĂƚĞĚ͘\u003Cbr>x ŝŶ ĂĚƵůƚƐ ǁĞŝŐŚŝŶŐ Ăƚ ůĞĂƐƚ ϰϱ ŬŐ ĂŶĚ ƉĞĚŝĂƚƌŝĐ ƉĂƚŝĞŶƚƐ ϭϮ LJĞĂƌƐŽĨ ĂŐĞ ĂŶĚ ŽůĚĞƌ ǁĞŝŐŚŝŶŐ Ăƚ ůĞĂƐƚ ϰϬ ŬŐ͗ ĨŽƌ ƉĂƌĞŶƚĞƌĂů ŶƵƚƌŝƚŝŽŶǁŚĞŶ ŽƌĂů Žƌ ĞŶƚĞƌĂů ŶƵƚƌŝƚŝŽŶ ŝƐ ŶŽƚ ƉŽƐƐŝďůĞ͕ ŝŶƐƵĨĨŝĐŝĞŶƚ ŽƌĐŽŶƚƌĂŝŶĚŝĐĂƚĞĚ͘ |\n| ZĞĐŽŵŵĞŶĚĞĚ ^EKD􀀜􀀘 􀀒d ŝŶĚŝĐĂƚŝŽŶ ĚŝƐĞĂƐĞ ƚĞƌŵ ĨŽƌĞĂĐŚ ŝŶĚŝĐĂƚŝŽŶ ;ŝĨĂƉƉůŝĐĂďůĞͿ |  |\n| ZĞĐŽŵŵĞŶĚĞĚ ĚŽƐŝŶŐƌĞŐŝŵĞŶ | 􀀘ŽƐŝŶŐ ĨŽƌ ďŽƚŚ ŝŶĚŝĐĂƚŝŽŶƐ ĐĂŶ ďĞ ĨŽƵŶĚ ŝŶ ^ĞĐƚŝŽŶ ϭϭ Ͳ >ĂďĞůŝŶŐ |\n\nŝŝ  \nsĞƌƐŝŽŶ ĚĂƚĞ͗ KĐƚŽďĞƌ ϭϮ͕ ϮϬϭϴ  \nTable of Contents  \ndĂďůĞ ŽĨ dĂďůĞƐ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ǀ ZĞǀŝĞǁĞƌƐ ŽĨ DƵůƚŝͲ􀀘ŝƐĐŝƉůŝŶĂƌLJ ZĞǀŝĞǁ ĂŶĚ 􀀜ǀĂůƵĂƚŝŽŶ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ǀŝ'ůŽƐƐĂƌLJ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘ǀŝŝŝϭ͘ 􀀜džĞĐƵƚŝǀĞ ^ƵŵŵĂƌLJ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ϭϭ͘ϭ͘ WƌŽĚƵĐƚ /ŶƚƌŽĚƵĐƚŝŽŶ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ϭϭ͘Ϯ͘ 􀀒ŽŶĐůƵƐŝŽŶƐ ŽŶ ƚŚĞ ^ƵďƐƚĂŶƚŝĂů 􀀜ǀŝĚĞŶĐĞ ŽĨ 􀀜ĨĨĞĐƚŝǀĞŶĞƐƐ ͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ Ϯϭ͘ϯ͘ 􀀑ĞŶĞĨŝƚͲZŝƐŬ 􀀄ƐƐĞƐƐŵĞŶƚ ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘","cbCaipzjYqNdurmp","https://ap.wps.com/l/cbCaipzjYqNdurmp","pdf",4955589,101,"English","# Review Overview\n## Multi-Discipline Review Sections\n## Drug Utilization and Dosing Regimen\n## Indications, Contraindications, and Regulatory Recommendations","[{\"question\":\"What is the document’s purpose in the NDA/BLA process?\",\"answer\":\"It provides a multi-discipline review summary for an NDA/BLA submission, integrating cross-discipline findings and evaluations to support regulatory decisions.\"},{\"question\":\"Which review areas are included?\",\"answer\":\"The document includes office director and cross-discipline team leader review, clinical review, non-clinical review, clinical pharmacology review, and statistical review.\"},{\"question\":\"What dosing and utilization information is captured?\",\"answer\":\"It lists proposed dosing regimen details for the intended patient population and describes administration format and dosage limits relevant to the proposed product use.\"}]","Multi-Discipline Review Summary Review - NDA/BLA Multi-Disciplinary Review and Evaluation | PDF",1789649799,255]