5a. Appendix to Chapter 5

  1. Sandy Weinberg

Published Online: 8 MAR 2011

DOI: 10.1002/9780470933510.ch5a

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

How to Cite

Weinberg, S. (2011) Appendix to Chapter 5, in Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470933510.ch5a

Author Information

  1. Atlanta, Georgia, USA

Publication History

  1. Published Online: 8 MAR 2011
  2. Published Print: 28 MAR 2011

ISBN Information

Print ISBN: 9780470552353

Online ISBN: 9780470933510

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Summary

This appendix contains sections titled:

  • Why is FDA Issuing this Guidance?

  • What Products are Eligible for this Program?

  • How Do You Request that FDA Engage An Independent Consultant?

  • Does Your Request Affect the Pdufa Meeting Management Goals?

  • How Many Times Can You Use this Program During the Development of Your Product?

  • Can You Recommend Consultants for the FDA to Engage?

  • What is the Status and Role of the Consultant?

  • Will We Always Grant Your Request?