Description
Book SynopsisThe 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.
Trade Review“The 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.” (
Pharmaceutical Outsourcing, April 2009)
Table of ContentsPreface ix
Chapter 1 Ten Rules for Drug Regulatory Submissions 1
Chapter 2 FDA Meeting Requests 44
Chapter 3 Orphan-Drug Applications 64
Chapter 4 Investigational New Drug Applications (INDs) 82
Chapter 5 New Drug Applications (NDAs) 120
Chapter 6 505(b)2 New Drug Applications (NDAs) 183
Chapter 7 Abbreviated New Drug Applications (ANDAs) 255
Chapter 8 Annual Reports 288
Chapter 9 International Regulatory Submissions 315
Carl A. Rockburne
Chapter 10 Future Issues in Regulatory Submissions 355
Index 367
