13 de agosto de 2019

FDA NEWS: Released Final Guidance "Child-Resistant Packaging Statements in Drug Product Labeling"

From: www.fda.gov

FDA today announced the availability of a final guidance for industry entitled "Child-Resistant Packaging Statements in Drug Product Labeling." 

This guidance will assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in their drug product labeling. 

The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. 

In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling nonprescription drug products approved under an NDA or ANDA and those that are marketed under the over-the-counter drug review. 

This guidance is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.

Click here, to access the document.