Potential Medication Error Risks With Investigational Drug Container Labels
May 18-19, 2021
FDA and the Reagan-Udall Foundation for the FDA held a virtual public meeting on the potential medication error risks with investigational drug container labels. We solicited 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.
May 18: 1 - 4pm | May 19: 10am - 1pm (eastern)
Meeting was held virtually.
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
Remarks by FDA
Panel 4: International Regulatory Perspectives
Panel 5: Institutional Review Board Perspectives
Panel 6: FDA Regulatory Perspectives
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 firstname.lastname@example.org no later than May 5, 2021.