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:
Guidebook for Drug Regulatory Submissions is more than a useful guideit 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.
Формат: Скан PDf
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
Guidebook for Drug Regulatory Submissions is more than a useful guideit 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.
Формат: Скан PDf
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