Description
Generic Pharmaceutical Patent and FDA Law covers Food and Drug Administration (FDA) approval of generic drugs and the interaction of patents and FDA law. A practitioners guide, it walks the reader through the stages of drug approval, identifying the critical issues in the process and advising the client about the issues and areas of concern or exploitation. It also discusses the areas that impact the interaction of patents and Food and Drug Administration law, including litigation. Features of this publication include: Provides a step-by-step process for understanding, strategizing, and litigating generic drug patent infringement Provides comprehensive background in patent and (FDA) regulatory law, integrating them into one cohesive bundle Dissects each complex issue into its parts and cross-references it to other issues Provides an excellent teaching tool for associates, partners, law clerks, judges, and financial managers Provides case studies, illustrations, and timelines Covers the generic drug industry exclusively, blending generic drug patent, and FDA issues Offers citations to cases.
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