U.S. Food & Drug Administration

Description

This enduring material focuses on the significance of CURE ID, an internet-based repository, that allows the global community to report novel uses of existing drugs for difficult-to-treat diseases through a website, a smartphone, or other mobile device. This activity describes the purpose of CURE ID along with potential improvements and future expansion of disease areas within the CURE ID app.

References

CURE ID Moves to Automated Data Collection in Light of COVID Pandemic: https://www.fda.gov/drugs/our-perspective/cure-id-moves-automated-data-collection-light-covid-pandemic
CURE ID Home Page: https://cure.ncats.io/home
CURE ID App Lets Clinicians Report Novel Uses of Existing Drugs: https://www.fda.gov/drugs/science-and-research-drugs/cure-id-app-lets-clinicians-report-novel-uses-existing-drugs
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases: https://www.fda.gov/news-events/press-announcements/fda-launches-app-health-care-professionals-report-novel-uses-existing-medicines-patients-difficult

Learning Objectives

Summarize the purpose of CURE ID and its relation in enhancing the FDA's role in supporting real-world data.
Discuss the significance and latest developments of CURE ID in providing accessibility to clinical experience of repurposing drugs when there is an immediate need of new treatments in the absence of drug development.
Describe the objective of CURE ID in potentially streamlining the transition of treatment discoveries into clinical trials, offering valuable clinical data to refine trial hypotheses and strategic designs.
Explain the uses of the tool within specialized patient populations such as pregnant people and neonates for whom treatment data is often limited.

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals, and physician assistants.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-027-H99-P, and ACPE Universal Activity Number JA0002895-0000-24-027-H99-T for 0.50 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 0.50 contact hour(s).

AAPA

FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.50 AAPA Category 1 CME credits. Approval is valid until January 17, 2027. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 0.50 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

Roach, Sara, PharmD, Pharmacist, FDA - I have the following relationship(s): Walgreens Pharmacy - Employee
Schito, Marco, PhD, Executive Director, Critical Path Institute - nothing to disclose
Stone, Heather, MPH, Health Science Policy Analyst, FDA/CDER - nothing to disclose

Planning Committee

Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
January 18, 2024

Expiration Date
January 17, 2027

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