Drug development in the United States; featured CME topic: southern medical journal.

The following section was designed for physicians in all specialties, especially those in primary care. The Southern Medical Association is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians. This CME activity was planned and produced in accordance with the ACCME Essentials. The Southern Medical Association designates this educational activity for a maximum of 1 Category 1 credit toward the AMA Physician's Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the activity. The Featured CME Topic is a CME activity developed and administered by the Southern Medical Association's Department of Education. To obtain Category 1 credit, follow the instructions at the end of the section.

Purpose and Objectives

Drug development in the United States is a complex process subject to numerous pressures. Scientific, socio-economic, ethical, regulatory, and legal demands often challenge the acceleration of drug research, development, and marketing. The ultimate goal is to bring safer and more effective medical products to patients in a timely manner, despite the numerous challenges that those who participate in their development face. After reading the following article, physicians will better understand the history and structure of the U.S. Food and Drug Administration, the current status of drug research and development, the steps associated with clinical and preclinical research, and the current challenges in drug development.

Disclosure

In publishing this section in Southern Medical Journal, the Southern Medical Association recognizes educational needs of physicians in all specialties, especially those in primary care, for current information regarding drug development in the United States. In this section, authors may have included discussions about drug interventions, whether approved or unapproved by the U.S. Food and Drug Administration. Therefore, it is incumbent on physicians reading this section to be aware of these factors in interpreting the contents and evaluating recommendations. Moreover, views of authors do not necessarily reflect the opinions of the Southern Medical Association. Every effort has been made to encourage the author to disclose any commercial relationships or personal benefit that may be associated with this section. If the author disclosed a relationship, it is indicated below. This disclosure in no way implies that the information presented is biased or of lesser quality, but allows participants to make informed judgments regarding program content.

Disclaimer

The primary purpose of this section in the Journal is education. Information presented and techniques discussed are intended to inform physicians of medical knowledge, clinical procedures, and experiences of physicians willing to share such information with colleagues. It is recognized that a diversity of professional opinions exists in the contemporary practice of medicine that influences the selection of methods and procedures. The views and approaches of authors are offered solely for educational purposes. The Southern Medical Association disclaims any and all liability for injury or other damages to any individual reading this section and for all claims that may result from the use of techniques and procedures presented in it.

Key Points

* The seven-question short gun questionnaire was modified from the much longer gun questionnaire.

* Of the 100 youths interviewed, 2 said that they had a gun and 38% said it would be easy to get a gun.

* The short gun questionnaire was found to be as reliable as the long version.

Date of Original Release: December 1, 2003

Term of Approval: 1 Year * Credit Expires: December 1, 2004

Estimated Time for Completion: 1 Hours

Sharon Wyatt Moore, MD

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