CBER 101 - Biologics License Application Process

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Performance Goals (con’t) Resubmitted <strong>Application</strong>s (Efficacy Supplements) • Class 1 – 90% in 2 months (90% in 4 mo.; 50 % in 2 mo.) • Class 2 – 90% in 6 months (90% in 6 mo.) • Clinical Hold Responses – 90% in 30 days • Major Dispute Resolution – 90% in 30 days • Special Protocol Assessments – 90% in 45 days C E B R
Dispute Resolution • Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level • SOPP 8005 Major Dispute Resolution <strong>Process</strong> (2/11/99) C E B R
Page 1 and 2: The Biologics License Application P
Page 3 and 4: Drug development phases: Discovery
Page 5 and 6: CBER Regulatory Authority • BIOLO
Page 7 and 8: What is in a BLA? • Form FDA 356h
Page 9 and 10: BLA - Product/Manufacturing Informa
Page 11 and 12: International Harmonization Using t
Page 13 and 14: • MRP Managed Review Process - De
Page 15 and 16: The Review Committee CONSTITUTED TO
Page 17 and 18: Responsibilities Regulatory Project
Page 19 and 20: Before the BLA is Submitted • Pre
Page 21 and 22: SUBMISSION TRACKING NUMBER aaaaaa.b
Page 23 and 24: Refuse To File • A refusal to fil
Page 25 and 26: Complete Review • Substantive rev
Page 27 and 28: Discipline Reviews (DRs) • A DR l
Page 29 and 30: Action Decision • After a complet
Page 31: PDUFA Resubmissions • Guidance fo
Page 35 and 36: •SGRA Rules of the Road for Revie
Page 37 and 38: Good Review Management Principles
Page 39 and 40: Good Review Management Principles
Page 41: Good Review Management Principles

CBER 101 - Biologics License Application Process

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