Weinberg Guidebook for Drug Regulatory Submissions

1. Auflage 2009
ISBN: 978-0-470-45617-0
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 392 Seiten, E-Book

Destined to become every regulatory director's essential desktopcompanion
rofessionals working to submit major documents to the Food andDrug Administration (FDA) are guaranteed to encounter numerousunexpected and daunting hurdles. Guidebook for Drug RegulatorySubmissions offers a readable and clearly written road map foreffective submission of documents for required regulatory reviewsduring drug development.
Demystifying this complex, high-stakes process, author andnationally recognized drug regulation expert Sandy Weinbergpresents professionals with authoritative tips, tools, and adviceincluding suggestions for preparation, checklists for submission,an FDA evaluation tool for review, and copies of relevant FDAguidelines.
As well, vital information is provided on the most common typesof 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 theindustry and the general public, as well as how these pressureswill change the general nature and specific aspects of thesubmissions process over the near future. In addition, retiredCanadian trade consul and regulatory consultant Carl Rockburneguest-authors a chapter comparing the FDA process to the four othermajor regulatory environments of Canada, the European Union, Japan,and Australia.
Guidebook for Drug Regulatory Submissions is more than a usefulguide--it is an essential tool to be kept on the desk of everyregulatory director, submissions manager, vice president ofRegulatory Affairs, and Food and Drug Administration reviewerresponsible for the process of drug regulatory submissions.

Autoren/Hrsg.

Weinberg, Sandy

Inhaltsverzeichnis

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

Über Autor(innen)

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.