FDA: NDA and IND Applications - Contemporary Decisions (Health Care Law Series)
LandMark Publications (Author)
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Review & Description
This casebook contains 92 federal court of appeals decisions that address issues surrounding the Food and Drug Administration's Investigational New Drug process and New Drug Applications. The selection of decisions spans from 2005 through the date of publication and is organized by federal circuit. The decisions are listed in the order of frequency of citation. The most cited decisions appear higher in each section.
The regulation and control of new drugs in the United States is based on the FDA's New Drug Application procedure. Since 1938, every newly proposed drug is subject to an approved NDA prior to approval for sale and distribution in the U.S. The NDA application is the vehicle through which a sponsor formally solicits approval from the FDA. If all the regulatory requirements are satisfied, the FDA approves a new pharmaceutical for sale and marketing in the U.S. The data gathered during animal studies and human clinical trials of an Investigational New Drug application become part of the NDA.
Product Details
- Amazon Sales Rank: #134373 in eBooks
- Published on: 2012-04-02
- Released on: 2012-04-02
- Format: Kindle eBook
- Number of items: 1
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