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AFRLSAWPTR20150010Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients A Multimeter Trial Martin A. Schreiber, MD; Belinda H. McCully, PhD; Laszlo N. Italy, MD; Samantha J. Underwood,
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Efficacy and safety refer to the effectiveness of a treatment or intervention in achieving its intended results, as well as its safety profile in terms of adverse effects and risks associated with its use.
Manufacturers, sponsors, or researchers of pharmaceuticals and medical devices are required to file efficacy and safety data with regulatory agencies.
Efficacy and safety data should be filled out following specific guidelines provided by regulatory agencies, including clinical trial results, statistical analysis, and information about side effects.
The purpose is to ensure that medical products are effective for their intended use and do not pose unacceptable risks to patients.
Information must include clinical trial data, adverse event reports, dosage, population studies, and any comparative efficacy measures.
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