US Product Labelling: FDA Guidance and Resources

DLRC recently attended the FDA’s Product Labelling Resources for Human Prescription Drugs webinar. Conferences and webinars offer an opportunity to understand the latest views of regulatory bodies and industry within the constantly evolving regulatory landscape. Keeping abreast of relevant developments enables DLRC to continue providing high quality consulting services to our growing list of clients developing medicines in the US.

The format of FDA labelling resources has recently been updated to promote accessibility and facilitate the production of high-quality labelling by industry. Labelling for human prescription medicines summarises essential information concerning the safety and efficacy of products. It is imperative that product labelling reflects the latest information available to ensure healthcare professionals and patients can make informed decisions regarding prospective treatments.

FDA’s prescription drug labelling resources were previously located on one lengthy webpage entitled “Prescription Drug Labelling Resources”. This webpage has been reorganised into seven webpages for industry and one for healthcare professionals and patients. This change provides a more streamlined experience for users and ensures that appropriate resources or information can be more easily identified.

The FDA highlighted that “current” labelling (DailyMed and FDALabel) may differ from the latest FDA-Approved labelling. This discrepancy can exist because the current labelling may include annual reportable changes or a “Changes Being Effected” labelling supplement that is undergoing FDA review. It is important that industry is aware of this potential discrepancy to ensure correct versioning is followed for prospective labelling updates.

The new labelling resources webpage now incorporates various searchable labelling and product databases. This change was made as the FDA recognises that industry frequently refers to these databases when creating or updating product labelling. A non-exhaustive list of the available searchable databases is provided below:

• DailyMed
• Drugs@FDA
• FDALabel
• Medication Guides
• CDER’s Novel Drugs and Biological Products
• Drug Safety Communications
• Emergency Use Authorisation
• REMS@FDA

The updated FDA webpage includes an individual dropdown per section of the Prescribing Information that features applicable guidance, explanatory presentations and any relevant Manual of Policies and Procedures (MAPPs). General guidance, information on regulations and prescribing information templates are also provided.

A webpage entitled “Patient Labelling Resources” covers the various guidance, regulations and templates on Instructions for Use, Medications Guides and Patient Packet Inserts (PPIs). The webpage outlines the different criteria for selecting which form of Patient Labelling should be provided with an application. For example, Medication Guides are required for medicines where patient labelling could be critical in preventing serious adverse reactions or ensuring a drug’s effectiveness.

Carton and container labelling resources are presented within their own section on the FDA labelling resources website. Cartons and containers are an essential component of the wider product labelling as they are highly visible to patients. Well-designed packaging maintains patient safety via reducing medication errors by healthcare professionals and patients. The FDA highlighted the importance of improving consistency between prescribing information and carton/container labelling. This is an important point for industry involved in designing carton and container labelling to consider as discrepancies increase the chances of medication errors. Specific guidance is also available for rarer product types such as injectables, inhalers and transdermal drugs.

The labelling requirements differ for specific product categories such as generic drugs and biological products. Generic, or Abbreviated New Drug Application (ANDA), licence holders must update their labelling in line with the last approved reference listed drug (RLD) labelling which can be found on Drugs@FDA. As such updates must be completed in a timely manner, industry are advised to subscribe to resources such as CDER’s Drug Safety Labeling Changes. Specific guidance is also available for biological drugs (including biosimilars) to communicate any unique requirements for these products and therefore ensure labelling is compliant.

Additionally, the FDA have created a Frequently Asked Questions (FAQ) page that covers a wide range of labelling topics. The FAQ page is intended to support industry by providing comprehensive information on the most common labelling issues. The FAQ page supplements the wider update to FDA’s labelling resources and includes numerous useful references and examples.

This webinar was provided by FDA to ensure that users can identify the appropriate resources for specific labelling deliverables during drug development and post-approval.

The key takeaway messages were:

• “Current” labelling may differ from FDA-approved labelling
• The FDA labelling resource webpage has been redesigned to incorporate searchable labelling and product databases
• Resources include sample templates and guidance per section of the Full Prescribing Information
• Specific guidance available, including examples, for carton and container labelling, generic drugs, biological drugs and SPL codes
• Introduction of an FAQ page for healthcare professionals and patients

FDA stated that they are committed to providing, maintaining and updating their labelling resources for human prescription medicines. This guarantees that industry have all the tools at their disposable to develop accurate and informative labelling to the benefit of patients and healthcare professionals.

This commitment is welcome as it ensures that DLRC can be confident that our regulatory support for clients reflects the latest information available. To help with your regulatory goals contact our experts using the links below.