Guidebook for Drug Regulatory Submissions

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Guidebook for Drug Regulatory Submissions

Name: Guidebook for Drug Regulatory Submissions
ISBN: 9780470456170

Sandy Weinberg

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Destined to become every regulatory director's essential desktop companionrofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. 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.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.

श्रेणियाँ:

Medicine

साल:

2009

संस्करण:

प्रकाशन:

Wiley

भाषा:

english

पृष्ठ:

387

ISBN 10: