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Summary

This public workshop will be hosted by the Office of Nonprescription Drugs (ONPD) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). The purpose of this workshop is to bring together stakeholders from FDA, academia, and industry to define characteristics of drug products that are considered “candy-like.” 

Alternatives to conventional solid oral tablets are becoming more prevalent in the nonprescription drug space as manufacturers seek to make drugs more palatable for consumers. However, many of these products are easily confused with candy and non-drug products, resulting in misuse and inadvertent overdose, particularly among young children. Currently, no clear definition of a candy-like drug product exists, and little research is available on consumer understanding of these products. Therefore, this workshop aims to discuss any available research in this space and aid in the development of approaches for outlining appropriate dosage forms and patient-focused outreach to better understand how candy-like characteristics are viewed by consumers.  

The workshop will include presentations and panel discussions on various topics related to solid oral “candy-like” dosage forms, including the following:

• formulation considerations for developing palatable drug products,
• implications of candy-like characteristics on medication adherence in pediatric and geriatric populations,
• assessment of accidental pediatric exposure to candy-like medications, and strategies to prevent medication overdose of candy-like medications. 

Goals and Objectives 

FDA is seeking ways to further define features of nonprescription drug products that could be considered “candy-like.” 

Meeting Agenda

• Agenda (PDF - 101 KB)

Registration

Please register online at Eventbrite.

Topics for Discussion 

• Formulation considerations for developing palatable drug products. 
• Characteristics of confectionary products. 
• Real world evidence of candy-like dosage forms in pediatric and elderly populations. 
• Adverse events related to ingestions with “candy-like” medications. 
• Strategies to prevent medication overdose.   

Visiting FDA Campus 

Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. 

Food and Drink 

Public meeting attendees may bring their own food and drink. However, the FDA cannot guarantee the use of a refrigerator or microwave. Light refreshments and sandwiches are often available for purchase at public meetings. Restaurants near the FDA White Oak campus are available, before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. 

Virtual Attendance Information 

This meeting will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the day before the meeting. 

Accessibility 

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities. 

Contact 

For additional details, contact the FDAs CDER/OND/Public Meeting Team at ONDPublicMTGSupport@fda.hhs.gov. 

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