Pharmaceutical Law R&D 101: Legal Issues During Research and Development

October 4, 2006 Download PDF

Developing a new drug or biological product is challenging and costly. Even minor missteps can significantly delay a product coming to market. Major missteps can add legal costs to the already mounting research and development costs that are required to prepare a new drug application (“NDA”) or a biologics license application (“BLA”). Preparing for the submission of an investigational new drug application is the first and most important step in the development of a new drug product. Understanding human subject protection requirements both in and outside of the United States is necessary, particularly if you intend to rely on foreign clinical trial results to demonstrate the safety and efficacy of your product. This includes knowing how to recruit subjects and whether you can charge volunteers for the drug product. Finally, knowing the legal and regulatory consequences of wrongful conduct will help ensure that you protect the integrity of your data and ensure ultimate market success.

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