Public | Virtual
Event Title
Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis; Public Workshop
October 23, 2025
- Date:
- October 23, 2025
- Time:
- 8:30 a.m. - 4:00 p.m. ET
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review is announcing a 1-day public workshop regarding the regulatory status of patch tests for contact dermatitis.
PURPOSE OF WORKSHOP:
This public workshop is intended to provide information about and gain perspective from health care providers, academia, and industry on approaches used for the review and approval of new patch test allergens for the diagnosis of allergic contact dermatitis. The input from this public workshop will help inform the Agency on the need for rapid approval of new patch test allergens, the utility of the Agency’s current approval paradigm, and proposals for alternative approaches that might be considered.
GOALS OF THE WORKSHOP:
- To inform stakeholders about the current regulatory status of patch tests to aid in the diagnosis of allergic contact dermatitis.
- To inform FDA regulators of up-to-date information about the diagnosis of allergic contact dermatitis using patch testing
- To inform stakeholders of the requirements to license to patch tests in the United States and European Union.
BACKGROUND:
Allergic contact dermatitis (ACD) is a common inflammatory skin disease that can severely affect quality of life and in the United States has an estimated annual cost exceeding $1 billion. Patch testing is the only validated test for diagnosing allergic contact dermatitis and is consider to be the gold standard. Once ACD is diagnosed and the contact allergen is defined, many patients can experience significant improvement by avoidance alone. For example, many patients who are allergic to nickel can avoid nickel-containing jewelry and accessories. Similarly, those with contact allergy to specific fragrances and preservatives used in cosmetics can avoid products containing those compounds. Some contact allergens, however, particularly those encountered in the workplace are harder to avoid (e.g., rubber gloves, acrylates, cement) and can severely affect quality of life. In these instances, ACD can be a chronic and even debilitating skin disease.
Since avoidance is essential to managing ACD, it is imperative to define the sensitizing allergen through patch testing. Traditionally, this has been done with Finn chambers, which are filled with the candidate allergen suspended in petrolatum jelly. This can also be performed with preprepared panels in which candidate allergens are applied to a plastic matrix. However only a limited number of allergens, including some of the most common allergens, are available in this format. Since these contact allergens collectively affect a substantial portion of ACD patients the limited number of allergens available in the preprepared patch test format is an impediment towards rapid diagnosis of many often severely affected patients.
Patch test panels are considered drugs that in the United States are regulated by the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). As is the case for any drugs regulated by CBER, new patch test panels are approved after submission of a Biological License Application (BLA) which includes results of placebo-controlled trials that assess the efficacy (i.e., sensitivity and specificity) and safety of each new allergen included in the panel. Since sensitivity to many of the individual allergens may be relatively uncommon, and the market for the panels may be relatively small, performing these trials may be prohibitively cumbersome and expensive. To address the need for more allergen panels other countries and regions, including Canada and the European Union, have adopted alternative approaches. For example, the European Medicines Agency has adopted an alternative licensing approach using “real world data.” The purpose of this workshop is to discuss the burden of ACD in the US, and to inform regulators of different approaches towards regulating patch tests with the intent of easing the burden of diagnosis of ACD.
TOPICS FOR DISCUSSION:
Representatives from federal government agencies, European and Canadian government agencies, academic, research, professional societies, industry representatives and lay members of the public will attend the meeting to discuss the pathophysiology of allergic contact dermatitis, current diagnostic tools, current approval paradigms, unmet needs, and possible solutions.
LOCATION:
This is a virtual event via Microsoft Teams.
REGISTRATION INFORMATION:
To register for the public workshop, please visit the following website: https://events.gcc.teams.microsoft.com/event/allergiccontactdermatitis
FOR FURTHER INFORMATION CONTACT:
Loni Warren Henderson or Stacey Rivette, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3030, Silver Spring, MD 20993, 240-402-8010, or 240-402-8020, or CBERPublicEvents@fda.hhs.gov (subject line: ACD Workshop).