Potential Medication Error Risks With Investigational Drug Container Labels
Public Meeting
May 18-19, 2021
Join us for this important conversation
FDA and the Reagan-Udall Foundation for the FDA invite you to a virtual public meeting on the potential medication error risks with investigational drug container labels. We are soliciting input from stakeholders (e.g., sponsors, investigators, clinical sites, entities that supply or label investigational drugs, and study participants) on the risk of medication errors related to the content and format of information on investigational drug container labels, the prevalence and nature of medication errors, and practices that might minimize the potential for such errors.
Schedule
May 18: 1 - 4pm | May 19: 10am - 1pm (eastern)
Meeting will be held virtually.
Agenda (tentative)
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Day 1 1:00 pm 1:05 pm 1:15 pm 2:15 pm 3:00 pm 4:00 pm |
Welcome FDA Opening Remarks Panel 1: Clinical Trial Site Perspectives Panel 2: Supplier/Contract Research Organization (CRO) Perspectives Panel 3: Industry (Sponsor) Perspectives Closing Remarks / Adjourn Day 1 |
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Day 2 10:00 am 10:05 am 10:15 am 11:15 am 11:45 am 12:45 pm 1:00 pm |
Welcome Remarks by FDA Panel 4: International Regulatory Perspectives Panel 5: Institutional Review Board Perspectives Panel 6: FDA Regulatory Perspectives Public Comment Closing Remarks / Adjourn |
For purposes of this meeting, an investigational drug means a drug or biological product that is used in a clinical investigation under an investigational new drug application.
If you need special accommodation, please contact admin@reaganudall.org no later than May 5, 2021.