Audioconference Title

Internal FDA Standards for Reviewers
Audioconference Date Tuesday September 22, 2009. 1:00 pm to 2:30 pm
Audioconference Description A discussion of standards and processes meant to improve FDA performance and the quality of submissions produced by regulated industry
Instructor information

Contact me for assistance
regarding the application of this information		 Joshua Sharlin, Ph.D.
Sharlin Consulting
Tel +1-301-570-1107
jsharlin@pipeline.com
www.speedupfda.com
These documents supplement information presented in the audioconference
Document Title Pages Check here to Download
1 FDA Guidance for Review Staff and Industry - Good Review Management Principles 20
2 CDER Manual - Formal Meetings Between CDER and CDERs External Constituents 11
3 FDA Guidance for Industry - Formal Meetings With Sponsors and Applicants for PDUFA Products 8
4 CBER Manual - Refusal to File Procedures for Biologic License Applications 13
5 Independent Evaluation of FDA's First Cycle Review Performance - Final Report 74