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.

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Schedule

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


Agenda (tentative)

Day 1

1:00 pm

1:05 pm

1:15 pm

2:15 pm

3:00 pm

4:00 pm

 

Welcome

Opening Remarks

Panel 1: Clinical Trial Site Perspectives

Panel 2: Supplier Perspectives

Panel 3: Industry Perspectives

Closing Remarks / Adjourn Day 1

Day 2

10:00 am

10:05 am

10:15 am

11:15 am

11:45 am

12:45 pm

1:00 pm

 

Welcome

Additional Remarks by FDA

Panel 4: International Regulatory Perspectives

Panel 5: Institutional Review Board Perspectives

Panel 6: FDA Regulatory Perspectives

Public Comment

Closing Remarks / Adjourn

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Investigational Drugs

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.

View Federal Register notice

 

If you need special accommodation, please contact admin@reaganudall.org no later than May 5, 2021.