Regulatory Focus™ > News Articles > 2019 > 7 > FDA Drafts Two New Guidances on Drug Labeling

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Posted 01 July 2019 | By Zachary Brennan 

FDA Drafts Two New Guidances on Drug Labeling

2753 The US Food and Drug Administration (FDA) on Monday released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling and another on the content and format of the Instructions for Use (IFU) of a medicine.

For the 12-page draft guidance on the “Drug Abuse and Dependence” section, FDA says the section should be concisely and clearly written to summarize the product’s “abuse potential, signs and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 section is composed of three subsections, described in depth in the draft: (1) Detailing if the drug is a controlled substance, if the DEA scheduling is still pending and what the active ingredient is; (2) Abuse, misuse and addiction information; (3) Dependence information, with information on physical dependence and withdrawal.

The draft guidance also discusses the formatting of the “Drug Abuse and Dependence” section and what not to include (i.e. speculative or promotional language, information on the disposal of controlled substances or lengthy definitions).

“Our goal is that this guidance will help ensure that information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful and informative,” Acting FDA Commissioner Ned Sharpless said in a statement that also points to the need for such clear labeling in opioid products.

The other draft guidance issued Monday is a 17-page source of help for those looking to develop consistent content and format across IFUs, which are developed to help patients with complicated instructions associated with using a drug or biologic.

The draft features sections on general and more specific content recommendations, as well as formatting recommendations, including page layout and design suggestions.

“FDA recommends that information appear as logically ordered, detailed, step-by-step instructions so that patients can safely and effectively take or administer the drug product. For drug products with more than one method of administration (for example, sprinkle capsule contents into food or drink; administer by feeding tube for patients who have difficulty swallowing), FDA recommends using distinct sections to separate the instructions for each administration method,” the draft says.

In addition to these two drug labeling draft guidances, FDA in January issued a draft guidance on developing the “Indications and Usage” section of product labeling for products approved under the accelerated approval pathway. And in March, FDA released a final guidance to assist applicants in determining the appropriate placement and content of pediatric labeling information to help ensure that information is consistently written and appropriately placed in labeling.

Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format


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