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