Multi-Discipline Review Summary Review - NDA/BLA Multi-Disciplinary Review and Evaluation

Sep 17, 2026

Upload by Blitz

Multi-discipline review summary for an NDA/BLA submission with application number 212121Orig1s000, prepared under the Center for Drug Evaluation and Research. The document records core administrative data such as priority and submission dates, applicant and proposed product information, and outlines cross-discipline assessments. It covers office director and team leader review structure, clinical and non-clinical evaluations, clinical pharmacology, statistical review, and includes drug utilization, dosing regimen, indications, and regulatory action recommendations including pharmacology and device-related context where applicable.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages101

Reading Time4 h 15 min

AccessFree to download

Review Overview

Multi-Discipline Review Sections

Drug Utilization and Dosing Regimen

Indications, Contraindications, and Regulatory Recommendations

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212121Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-Disciplinary Review and Evaluation | 􀀄ƉƉůŝĐĂƚŝŽŶ ƚǇƉĞ | E􀀘􀀄 | | --- | --- | | 􀀄ƉƉůŝĐĂƚŝŽŶ ŶƵŵďĞƌ;ƐͿ | ϮϭϮϭϮϭ | | WƌŝŽƌŝƚǇ Žƌ ƐƚĂŶĚĂƌĚ | WƌŝŽƌŝƚǇ | | ^Ƶďŵŝƚ ĚĂƚĞ;ƐͿ | ϯͬϭϴͬϮϬϭϵ | | ZĞĐĞŝǀĞĚ ĚĂƚĞ;ƐͿ | ϯͬϭϵͬϮϬϭϵ | | W􀀘h&􀀄 ŐŽĂů ĚĂƚĞ | ϵͬϭϵͬϮϬϭϵ | | 􀀘ŝǀŝƐŝŽŶͬŽĨĨŝĐĞ | 􀀘ŝǀŝƐŝŽŶ ŽĨ 'ĂƐƚƌŽĞŶƚĞƌŽůŽŐǇ ĂŶĚ /ŶďŽƌŶ 􀀜ƌƌŽƌƐ WƌŽĚƵĐƚƐ;􀀘'/􀀜WͿͬKĨĨŝĐĞ ŽĨ 􀀘ƌƵŐ 􀀜ǀĂůƵĂƚŝŽŶ /// ;K􀀘􀀜 ///Ϳ | | ZĞǀŝĞǁ ĐŽŵƉůĞƚŝŽŶ ĚĂƚĞ | ϵͬϭϵͬϮϬϭϵ | | 􀀜ƐƚĂďůŝƐŚĞĚͬƉƌŽƉĞƌ ŶĂŵĞ | WKd􀀄^^/hD W,K^W,􀀄d􀀜^ /E:􀀜􀀒d/KE | | ;WƌŽƉŽƐĞĚͿ ƚƌĂĚĞ ŶĂŵĞ | EŽŶĞ | | WŚĂƌŵĂĐŽůŽŐŝĐ ĐůĂƐƐ | WĂƌĞŶƚĞƌĂů WŚŽƐƉŚŽƌƵƐ ZĞƉůĂĐĞŵĞŶƚ | | 􀀒ŽĚĞ ŶĂŵĞ | | | 􀀄ƉƉůŝĐĂŶƚ | 􀀒DW 􀀘ĞǀĞůŽƉŵĞŶƚ >>􀀒 | | 􀀘ŽƐĂŐĞ ĨŽƌŵ | /ŶũĞĐƚŝŽŶ͗ ƉŚŽƐƉŚŽƌƵƐ ϰϱ ŵŵŽůͬϭϱ ŵ> ;ϯ ŵŵŽůͬŵ>Ϳ ĂŶĚ ƉŽƚĂƐƐŝƵŵϳϭ ŵ􀀜Ƌͬϭϱ ŵ> ;ϰ͘ϳ ŵ􀀜Ƌͬŵ>Ϳ ŝŶ Ă ƐŝŶŐůĞͲĚŽƐĞ ǀŝĂů͘ | | 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚ ĚŽƐŝŶŐƌĞŐŝŵĞŶ;ĐŽŶƚŝŶƵĞĚ ďĞůŽǁͿ | dŚĞ ĚŽƐĞ ĂŶĚ ƌĂƚĞ ŽĨ ŝŶĨƵƐŝŽŶ ŽĨ ƚŚĞ ƉƌŽƉŽƐĞĚ ƉƌŽĚƵĐƚ ĂƌĞĚĞƉĞŶĚĞŶƚ ŽŶ ƚŚĞ ŝŶĚŝǀŝĚƵĂů ŶĞĞĚƐ ŽĨ ƚŚĞ ƉĂƚŝĞŶƚ͗
&Žƌ ƚƌĞĂƚŵĞŶƚ ŽĨ ŚǇƉŽƉŚŽƐƉŚĂƚĞŵŝĂ͗
􀀄ĚƵůƚƐ͗ dŚĞ ŵĂǆŝŵƵŵ ĚŽƐĂŐĞ ŝƐ ϰϱ ŵŵŽů ƉŚŽƐƉŚŽƌƵƐ ƉĞƌ ĚĂǇ͘
􀀘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
(b) (4)
,ŽǁĞǀĞƌ͕ ďĂƐĞĚ ŽŶ ĐůŝŶŝĐĂů ƌĞƋƵŝƌĞŵĞŶƚƐ͕ƐŽŵĞ ƉĂƚŝĞŶƚƐ ŵĂǇ ƌĞƋƵŝƌĞ ŚŝŐŚĞƌ Žƌ ůŽǁĞƌ ĚŽƐĂŐĞƐ͘

(b) (4) | ŝ sĞƌƐŝŽŶ ĚĂƚĞ͗ KĐƚŽďĞƌ ϭϮ͕ ϮϬϭϴ | 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚ ĚŽƐŝŶŐƌĞŐŝŵĞŶ;ĐŽŶƚŝŶƵĞĚͿ | (b) (4) | | --- | --- | | 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚŝŶĚŝĐĂƚŝŽŶ;ƐͿͬƉŽƉƵůĂƚŝŽŶ;ƐͿ | /Ŷ ĂĚƵůƚƐ ĂŶĚ ĂĚŽůĞƐĐĞŶƚ ƉĂƚŝĞŶƚƐ ϭϮ ƚŽ фϭϴ ǇĞĂƌƐ ŽĨ ĂŐĞ͗
x ĂƐ Ă ƐŽƵƌĐĞ ŽĨ ƉŚŽƐƉŚŽƌƵƐ͕ ĨŽƌ ĂĚĚŝƚŝŽŶ ƚŽ ůĂƌŐĞ ǀŽůƵŵĞŝŶƚƌĂǀĞŶŽƵƐ ĨůƵŝĚƐ͕ ƚŽ ƉƌĞǀĞŶƚ Žƌ ĐŽƌƌĞĐƚ ŚǇƉŽƉŚŽƐƉŚĂƚĞŵŝĂŝŶ ƉĂƚŝĞŶƚƐ ǁŝƚŚ ƌĞƐƚƌŝĐƚĞĚ Žƌ ŶŽ ŽƌĂů ŝŶƚĂŬĞ͘
x ĂŶ ĂĚĚŝƚŝǀĞ ĨŽƌ ƉƌĞƉĂƌŝŶŐ ƐƉĞĐŝĨŝĐ ƉĂƌĞŶƚĞƌĂů ĨůƵŝĚ ĨŽƌŵƵůĂƐǁŚĞŶ ƚŚĞ ŶĞĞĚƐ ŽĨ ƚŚĞ ƉĂƚŝĞŶƚ ĐĂŶŶŽƚ ďĞ ŵĞƚ ďǇ ƐƚĂŶĚĂƌĚĞůĞĐƚƌŽůǇƚĞ Žƌ ŶƵƚƌŝĞŶƚ ƐŽůƵƚŝŽŶƐ͘ | | 􀀄ƉƉůŝĐĂŶƚͲƉƌŽƉŽƐĞĚ^EKD􀀜􀀘 􀀒d ŝŶĚŝĐĂƚŝŽŶĚŝƐĞĂƐĞ ƚĞƌŵ ĨŽƌ ĞĂĐŚƉƌŽƉŽƐĞĚ ŝŶĚŝĐĂƚŝŽŶ | | | ZĞĐŽŵŵĞŶĚĂƚŝŽŶ ŽŶƌĞŐƵůĂƚŽƌǇ ĂĐƚŝŽŶ | 􀀄ƉƉƌŽǀĂů ĨŽƌ ďŽƚŚ ƉŚŽƐƉŚŽƌƵƐ ƌĞƉůĂĐĞŵĞŶƚ ŝŶ ŝŶƚƌĂǀĞŶŽƵƐ ĨůƵŝĚƐ ĂŶĚŝŶ ƚŽƚĂů ƉĂƌĞŶƚĞƌĂů ŶƵƚƌŝƚŝŽŶ | | ZĞĐŽŵŵĞŶĚĞĚ
ŝŶĚŝĐĂƚŝŽŶ;ƐͿͬƉŽƉƵůĂƚŝŽŶ;ƐͿ;ŝĨ ĂƉƉůŝĐĂďůĞͿ | WKd􀀄^^/hD W,K^W,􀀄d􀀜^ /E:􀀜􀀒d/KE ŝƐ Ă ƉŚŽƐƉŚŽƌƵƐ ƌĞƉůĂĐĞŵĞŶƚƉƌŽĚƵĐƚ ŝŶĚŝĐĂƚĞĚ ĂƐ Ă ƐŽƵƌĐĞ ŽĨ ƉŚŽƐƉŚŽƌƵƐ͗
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
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 | | ZĞĐŽŵŵĞŶĚĞĚ ^EKD􀀜􀀘 􀀒d ŝŶĚŝĐĂƚŝŽŶ ĚŝƐĞĂƐĞ ƚĞƌŵ ĨŽƌĞĂĐŚ ŝŶĚŝĐĂƚŝŽŶ ;ŝĨĂƉƉůŝĐĂďůĞͿ | | | ZĞĐŽŵŵĞŶĚĞĚ ĚŽƐŝŶŐƌĞŐŝŵĞŶ | 􀀘ŽƐŝŶŐ ĨŽƌ ďŽƚŚ ŝŶĚŝĐĂƚŝŽŶƐ ĐĂŶ ďĞ ĨŽƵŶĚ ŝŶ ^ĞĐƚŝŽŶ ϭϭ Ͳ >ĂďĞůŝŶŐ | ŝŝ sĞƌƐŝŽŶ ĚĂƚĞ͗ KĐƚŽďĞƌ ϭϮ͕ ϮϬϭϴ Table of Contents dĂďůĞ 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 ͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘͘ ͘͘͘͘͘͘͘͘

FAQs

What is the document’s purpose in the NDA/BLA process?

It provides a multi-discipline review summary for an NDA/BLA submission, integrating cross-discipline findings and evaluations to support regulatory decisions.

Which review areas are included?

The document includes office director and cross-discipline team leader review, clinical review, non-clinical review, clinical pharmacology review, and statistical review.

What dosing and utilization information is captured?

It lists proposed dosing regimen details for the intended patient population and describes administration format and dosage limits relevant to the proposed product use.

Sep 17, 2026

Upload by Blitz