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The Tactics of Modern-Day Regulatory Trials
Ricardo E. Dent-Acosta, MD1; Neal Storm, MS, MBA, RAC1; Randall S. Steiner, MS, DPA1; Javier San Martin, MD1
1 Amgen Bone Therapeutic Area, One Amgen Center Drive, MS 38-2-C, Thousand Oaks, CA 91320. E-mail address for R.E. Dent-Acosta: rdent@amgen.com
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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at Amgen Inc., Thousand Oaks, California

Disclaimer: The views expressed herein represent those of the authors and do not necessarily reflect the views or practices of the authors’ employer or any other party.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):39-44. doi: 10.2106/JBJS.L.00194
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Fractures are an important public health problem affecting patients of all ages. Although most fractures heal quickly, some heal poorly and some do not heal at all. To achieve an optimal healing outcome, the standard of care for most fractures consists of reduction followed by immobilization, with a myriad of options regarding the approach to fracture-healing. Currently, biopharmaceutical companies are sponsoring research with regard to products that aim to enhance or accelerate fracture-healing; however, as there are no approved and marketed systemic therapies for fracture-healing, the development and commercialization process for such products will require close collaboration between industry, academia, and regulators to determine how to bring these products to market in the most efficient manner. The following manuscript provides a brief overview of the regulatory process in the United States for systemic therapies in fracture-healing and discusses key issues that may arise in connection with the regulatory approval of these novel investigational treatments.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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