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Drug Book from C.H.I.P.S.

Guidebook for Drug Regulatory Submissions
by Sandy Weinberg

Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.

Guidebook for Drug Regulatory Submissions includes:

  • Meeting Requests
  • Orphan Drug Applications
  • Investigatory New Drug Applications (INDAs)
  • New Drug Applications (NDAs)
  • 505(b)2 NDAs
  • Abbreviated New Drug Applications (ANDAs)
  • Annual Report

Contents

  1. Ten Rules for Drug Regulatory Submissions
  2. FDA Meeting Requests
  3. Orphan Drug Applications
  4. Investigatory New Drug Applications (INDs)
  5. New Drug Applications (NDAs)
  6. 505(b)2 New Drug Applications
  7. Abbreviated New Drug Applications (ANDAs)
  8. Annual Reports
  9. International Submissions
  10. Future Issues in Regulatory Submissions

Index

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Guidebook for Drug Regulatory Submissions
by Sandy Weinberg
2009 379 pages $98.95 + shipping
Texas residents please add 6.75 % sales tax

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