FDA, The USA Drug Regulator, Published Guidance for Industry on Label Comprehension Studies for Non-Prescription Drug Products

Full Text Here

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This guidance is intended to provide recommendations to industry on conducting label comprehension studies. A label comprehension study assesses the extent to which consumers understand the information on nonprescription drug product labeling and then apply this information when making drug product use decisions in a hypothetical situation. Data derived from a label comprehension study can identify areas on the label that would benefit from clearer or simpler presentation of important consumer information.
It is important to note that label comprehension study data do not predict consumer behavior (e.g., how consumers actually use a drug product). Drug product use and other behaviors are often evaluated in an actual use study. We recommend that the label used in an actual use study be tested in a label comprehension study beforehand to ensure that consumers understand the information on the label.
This guidance covers general principles related to the conduct of label comprehension studies and should not be considered a substitute for an FDA review of specific protocols. This guidance incorporates advice obtained from the September 25, 2006, meeting of the Nonprescription Drug Advisory Committee that considered issues related to analysis and interpretation of consumer studies conducted to support marketing of nonprescription drugs,2 and comments received regarding the draft guidance published on May 1, 2009.

For Acecss to a CMC Expert Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”