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Times:

May 18: 1 - 4pm | May 19: 10am - 1pm (eastern)
Meeting will be held virtually.

Dates:

The public meeting will be held virtually and broadcast via webcast on May 18, 2021 (Tuesday), from 1 p.m. to 4 p.m. (Eastern Time), and May 19, 2021 (Wednesday), from 10 a.m. to 1 p.m. (Eastern Time). 

BACKGROUND

The Food and Drug Administration will hold the Potential Medication Error Risks With Investigational Drug Container Labels Public Meeting May 18-19, 2021. This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and the FDA.

Goals and Objectives

The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, investigators, clinical sites, contract research organizations and other entities that supply or otherwise label investigational drugs, regulators, professional organizations, and study participants) on the risk of medication errors potentially related to the content and format of the information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.
During the public meeting, speakers and participants will cover a range of issues related to medication errors and investigational drugs. Discussion topics related to the format and content of information on investigational drug container labels include:

• The prevalence and types of medication errors attributed to container labels
• The impact of such errors on clinical investigations
• Information that should always be on the container label, and how that information should be presented to facilitate safe use
• Entities responsible for labeling containers
• Existing processes for reporting and analyzing medication errors and complaints related to container labels
• Global regulatory convergence and differences for the information on container labels

Registration

To register for the public meeting, complete the registration form at https://reaganudall.org/news-and-events/events/investigational-drug-labels. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Registration is free.

• Federal Register Notice

Contact

Jo Wyeth, Center for Drug Evaluation and Research, Food and Drug Administration
Jo.Wyeth@fda.hhs.gov