Sabre Foundation

To my wife, Sylvia. Without her support and encouragement, completion of this book would not have been possible.

FDA Statement:

This book reflects the views of the author and should not be construed to represent the FDA's views or policies.

All drugs and medical devices used in the United States are administered in accordance with Food and Drug Administration (FDA) regulations (1). These regulations vary depending on the risks associated with the drug or medical device, the similarity of the drug or medical device to products already on the market, and the quality and scope of clinical data available.

Some drugs and medical devices described in this publication or referenced publications have not been approved or cleared by the FDA or have been cleared by the FDA for use for specific purposes or for use only in restricted research settings. The FDA has stated that it is the responsibility of the physician to determine the FDA status of each drug or device he or she wishes to use in clinical practice, and to use the products with appropriate patient consent and in compliance with applicable law.

When an approved drug, biologic, or medical device is used in a way that is different from that described in the FDA-approved label or a cleared medical device is used in a way that is not included in the cleared "indications for use," it is considered to be an "off-label" use (2). If a physician uses a product for an indication not in the approved or cleared labeling, the physician has the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain awareness of the product's use and effects (3). The FDA is a source for information regarding approved labeling and indications for use of medical products.

References

1. United States Food and Drug Administration: http://www.fda.gov

2. Off-Label Use of Medical Products: American Academy of Orthopedic Surgeons Position Statement #1177: http://www.aaos.org/about/papers/position/1177.asp

3. "Off-Label" and Investigational Use of Marketed Drugs, Biologics, and Medical Devices - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators: http://www.fda.gov/RegulatoryInformation/ Guidances/ucm126486.htm

Additional Notice:

The appearance of any product name or registered design without designation as proprietary is not to be construed as a representation that the name or design is in the public domain.

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