FDA Posts Guidance on Physician Drug Labeling Requirements
The Food and Drug Administration said a guidance is now available on industry implementation of Physician Labeling Rule content and format requirements in labeling for human drug and biological products. FDA said the guidance will assist applicants in developing labeling…
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for new products, revising existing labeling, and implementing the physician labeling requirements. The Physician Labeling Rule, published in 2006, addresses prescription drug labeling that is used by prescribers and other health care practitioners. Comments on the guidance may be submitted at any time, FDA said. The guidance is available here.