Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL41: Some Thoughts on Section 14 of Prescription Drug Labeling (300873)

*Mingyu Xi, FDA 

Keywords: labeling, section 14

Room: Wilson C

The primary purpose of prescription drug labeling is to give healthcare professionals the information they need to prescribe drugs appropriately. Some of the requirements of the labeling includes: accurate in summarizing of the safe and effective use of the drug, informative and accurate, not promotional, false or misleading, not implicative of claims or suggestive of the use if evidence of safety or effectiveness is lacking. Section 14 of drug labeling is known as clinical studies section. It includes information from the adequate and well-controlled studies that demonstrate the effectiveness of the drug for its approved indication. Results from the statistical review usually are presented in this section. At the labeling meeting what to include and what not to include in the label and how to present the results are the main focuses. Discussions can cover various statistical topics, such as, pre-specified endpoints versus not pre-specified, testing hierarchy, analysis population, estimand, point-estimate, standard error, confidence interval, p-value, significance level. The purpose of this round table discussion is to share the experience among the participants in their therapeutic areas, from industry or regulatory. Through the communication we understand better about the labeling requirements and identify the best practice in writing Section 14.