Science/Engineering Guidebook for Drug Regulatory Submissions (0470371382)

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Sandy Weinberg, "Guidebook for Drug Regulatory Submissions"

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.

As well, vital information is provided on the most common types of submissions, including:

* 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

This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.

Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

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	New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics New Drug Development: Regulatory Paradigms for Clinical Pharmacology and BiopharmaceuticsPublisher: Informa Healthcare \| 2004-05-24 \| ISBN 0824754654 \| Pages: 500 \| PDF \| 5 MBHighlighting key points from the latest regulatory requirements, ...
	Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives Herbal Supplements-Drug Interactions: Scientific and Regulatory PerspectivesPublisher: Informa Healthcare \| 2006-06-07 \| ISBN 0824725387 \| Pages: 360 \| PDF \| 7.2 MBThe international popularity of herbal remedies has recently outpaced qualit ...
	Business/Investing Securities Regulatory Handbook: 2001-2002 (Pricewaterhousecoopers Regulatory Handbooks) PricewaterhouseCoopers, "Securities Regulatory Handbook: 2001-2002 (Pricewaterhousecoopers Regulatory Handbooks)"Publisher: M.E. Sharpe \| 2001 \| ISBN 0765606542 \| PDF \| 144 pages \| 4.6 MBA guide, for financial institutions, to constraints o ...
	Economics/Finances The Consumer Banking Regulatory Handbook: 2001-2002 (Pricewaterhousecoopers Regulatory Handbooks) PricewaterhouseCoopers, "The Consumer Banking Regulatory Handbook: 2001-2002 (Pricewaterhousecoopers Regulatory Handbooks)"Publisher: M.E. Sharpe \| 2001 \| ISBN 0765606526 \| PDF \| 248 pages \| 14.54 MBThis work was compiled with the aim of ke ...
	Technical The Regulatory Reporting Handbook: 2001-2002 (Pricewaterhousecoopers Regulatory Handbooks) ISBN: 0765606550 Publisher: M.E. Sharpe Author: PricewaterhouseCoopersDescription:A guide to all the regulatory reports financial institutions are required to file. Topics covered include forms and reports for securities activities, anti-bo ...
	Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives (Drugs and the Pharmaceutical Sciences) Author: Publisher: Informa HealthCare (2006)Binding: Hardcover, 360 pagespricer: $199.95ISBN-10: 0824725387editorialreviewsThe international popularity of herbal remedies has recently outpaced quality information on the utilization and dosi ...

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