CBER 101 - Biologics License Application Process

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Who Submits a BLA ? MANUFACTURER (Applicant) • Any legal person or entity who is engaged in manufacture or • An applicant for a license who takes responsibility for compliance with product and establishment standards C E B R
What is in a BLA? • Form FDA 356h (cover sheet) • Applicant Information • Product / Manufacturing information • Pre-clinical studies • Clinical studies • Labeling C E B R
Page 1 and 2: The Biologics License Application P
Page 3 and 4: Drug development phases: Discovery
Page 5: CBER Regulatory Authority • BIOLO
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 and 32: PDUFA Resubmissions • Guidance fo
Page 33 and 34: Dispute Resolution • Guidance for
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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