FDA Policy/General

Drug Name Study on Consumer/Doc Interpretations

Federal Register notice: FDA is seeking public comments on a proposed information collection entitled “Text Analysis of Proprietary Drug Name Interpretations.” As part of the prescription drug regulatory review process, sponsors propose proprietary names for their products, and this proposed research is intended to help the agency determine whether names overstate a drug’s efficacy or safety or suggest superiority without substantiation, among other concerns.

Specifically, the research would determine how consumer and primary care physician (PCP) populations interpret prescription drug names, which will assist CDER Office of Prescription Drug Promotion’s (OPDP) consideration of promotional implications. FDA says the key objectives are: 1. To apply new techniques such as topic modeling and sentiment analysis (forms of text analysis) to answer OPDP’s research questions about consumer and PCP interpretations of proprietary prescription drug names. 2. To help develop a methodological approach for assessing consumer and prescriber interpretations of drug names, which can potentially be used in the future as a standard assessment tool.

To view the notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome