CBER 101 - Biologics License Application Process

More documents

Recommendations

Info

Information Requests (IRs) • Issued while the review is in progress • Requests information needed to continue the review • IRs may be made by letter, telephone or FAX • IRs are documented in the file • The response to an information request should not be so great as to constitute a major amendment • Responses to information requests do not necessarily have to be reviewed in the current review cycle • DOES NOT STOP THE REVIEW CLOCK • SOPP 8401.1 C E B R
Discipline Reviews (DRs) • A DR letter is issued when a particular discipline (clinical, CMC, etc.) has finished its review, but the complete review is not yet done • A DR letter contains comments and questions that might appear in the action letter • Responses to DR letters need not necessarily be reviewed prior to issuance of the action letter • DOES NOT STOP THE REVIEW CLOCK • SOPP 8401.1 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: Complete Review • Substantive rev
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

Create successful ePaper yourself

Delete template?

Save as template?