About
the Book:
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. |
Contents: 1.
Ten Rules for Drug Regulatory Submissions 2.
FDA Meeting Requests 3.
Orphan-Drug Applications 4.
Investigational New Drug Applications (INDs) 5.
New Drug Applications (NDAs) 6.
505(b)2 New Drug Applications (NDAs) 7.
Abbreviated New Drug Applications (ANDAs) 8.
Annual Reports 9.
International Regulatory Submissions 10. Future
Issues in Regulatory Submissions |
