Guidebook for Drug Regulatory Submissions

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

Preface 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