FDA issues two new drafted guidelines on drug labeling


The Drug and Dependence section receives an all-new, 12 paged, drafted guidelines emphasizing on maintaining clarity and precision in the packaging and labeling of the drugs. It must clearly state the “abuse potential, signs and symptoms of withdrawal, and abuse-deterrent properties (if applicable) and to provide information that is important for the safe and effective use of the product.”  

The drafted guideline by the FDA also raises concerns regarding major personal and physical issues. The acting FDA Commissioner Ned Sharpless said, "Our goal is that this guidance will help ensure that information in the product labeling on abuse, misuse, addiction, physical dependence, and tolerance is clear, concise, useful and informative." Apart from this, the opioid drugs must also have a clear indication in its labeling.