The US Food and Drug Administration is to involve 480 health care professionals this summer in a study to test doctors' reactions to its proposed new drug labeling formats.
According to Murray Lumpkin, deputy director for review management at the FDA Center for Drug Evaluation and Research, in much US drug labeling currently the sections dealing with adverse events and adverse reactions read just like "a big, huge laundry list of terms," the relevance of which is very hard to see "when you've got a patient who's having an actual problem."
The study may also measure physician performances in applying the new labeling formats in actual patient situations.
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