Potential Medication Error Risks With Investigational Drug Container Labels

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.

2019 Annual Public Meeting

Annual Public Meeting Set for May 2, 2019

Each year, the Foundation conducts an annual public meeting to discuss its activities and support of the U.S. Food and Drug Administration. The 2019 Annual Public Meeting will focus on pressing FDA initiatives suitable for Public-Private Partnerships and will be held from 10 a.m. until noon on May 2, 2019, at the following location:

PEW Charitable Trust

901 E Street, NW, Suite 1700

Washington, DC 20004

Collecting Data from EA Treatment for Regulatory Submissions Presentation

Executive Director June Wasser will present Collecting Data from EA Treatment for Regulatory Submissions at the Life Science Compassionate Access Summit at 4:00 pm, Monday, March 18th in Philadelphia. She will focus on: 

  • Defining challenges and opportunities for data collection in an EA setting;
  • Offering perspectives on data collection from different stakeholders; and
  • Are the current EA regulations sufficient?