Guidebook for Drug Regulatory Submissions

By:

Weinberg, Sandy

Material type: Text

TextPublication details: New Jersey John and Wiley Sons, Inc. 2009Description: 379pISBN:

9780470371381

DDC classification:

344.7304233 WEI

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Holdings
Item type	Current library	Item location	Collection	Call number	Status	Date due	Barcode	Item holds
Reference Book	NIMA Knowledge Centre	7th Floor Silence Zone	Reference	344.7304233 WEI (Browse shelf(Opens below))	Not For Loan		P0006995

Total holds: 0

Destined to become every regulatory director's essential desktop companion.rofessionals 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.

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