Guidebook for drug regulatory submissions
By: Sandy Weinberg.
Publisher: John Wiley
Published: 2009
Place of publication: Hoboken, N.J
Language: eng
Number of pages: 379
ISBN-13: 9780470371381
Subjects: Drugs -- Law and legislation -- United States; Drug approval -- United States; Drug Approval -- United States; Drugs, Investigational -- United States
Description: The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and.
Notes: Includes bibliographical references and index.
Table of contents: title: Rules for drug regulatory submissions; title: FDA meeting requests; title: Orphan drug applications; title: Investigatory new drug applications (INDS); title: New drug applications (NDAS); title: 505(b)2 new drug applications; title: Abbreviated new drug applications (ANDAS); title: Annual reports; title: International submissions / by Carl A. Rockburne; title: Future issues in regulatory submissions.