Guidebook for Drug Regulatory Submissions by Sandy Weinberg

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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

Ten Rules for Drug Regulatory Submissions
FDA Meeting Requests
Orphan Drug Applications
Investigatory New Drug Applications (INDs)
New Drug Applications (NDAs)
505(b)2 New Drug Applications
Abbreviated New Drug Applications (ANDAs)
Annual Reports
International Submissions
Future Issues in Regulatory Submissions