University of California, Irvine

Official Statements

Score contribution: 100 — 4 supporting sources.

Score 1004 references

Featured Reference

Expanded Access to Unapproved Drugs or Biologics - UCI Office of ResearchOpens in new window

“Under FDA regulations (21 CFR 312.300), expanded access allows for the use of unapproved drugs and biologics outside of a clinical trial for patients with serious diseases or conditions when there is no satisfactory alternative therapy to treat the patient’s disease or condition. While expanded access is not considered a clinical investigation, FDA submission and IRB review are required.”

Expanded Access to Unapproved Medical Devices - UCI Office of ResearchSource

“There are two options for treating patients with an unapproved medical device outside of a clinical trial. One option is Expanded Access. The other is Right to Try.”

REQUEST FOR EMERGENCY APPROVAL FOR USE OF _Source

“When a patient has an immediately life-threatening disease or condition that is not addressed by current approved treatments, options exist in the State of California through Right to Try laws to allow patients access to drugs or biologics that have not been approved by the Food and Drug Administration (FDA).”

University of California, Irvine Human Research Protections ...Source

“FDA regulations allow certain individuals not enrolled in clinical trials to obtain expanded access to investigational drugs, agents, or biologics through the following methods: Compassionate Use, Group C Treatment Investigational New Drug (IND), Open – Label Protocol, Parallel Track, Treatment IND or Biologics, Single-Patient Use, Emergency IND, IND Exemptions in the Treatment of Cancer.”

EAP Related Articles from Sponsor

Score contribution: 80 — 3 supporting sources.

Score 803 references

Featured Reference

Right to Try for Unapproved Drugs or Biologics - UCI Office of ResearchOpens in new window

UCI will comply with California’s RTT law requirements. **\*\*Because the federal RTT law does not address the use of investigational devices** _**UCI will not provide investigational devices to patients outside of the FDA’s expanded access program ( [HRPP Policy #41](https://research.uci.edu/human-research-protections/policies/), [21 CFR Part 300](https://www.govinfo.gov/content/pkg/FR-2022-09-14/pdf/2022-19737.pdf)).**_

UC Irvine Amyotropic Lateral Sclerosis (ALS) Trial: RAPA-501 Therapy of ALS Expanded Access ProtocolSource

RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 T stem cells in patients living with amyotrophic lateral sclerosis (pwALS).

UC Irvine Amyotropic Lateral Sclerosis (ALS) Clinical Trials — Orange County, CASource

RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 T stem cells in patients living with amyotrophic lateral sclerosis (pwALS). The primary objective of the intermediate expanded access protocol is to provide access to the investigational product, CNM-Au8, to up to 300 people living with ALS (pALS).

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 1 supporting sources.

Score 401 references

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TheraSphere® for Treatment of Unresectable Hepatocellular CarcinomaOpens in new window

Conditions: Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Primary Liver Cancer

Expanded Access Intelligence

Official Statements

Past EAPs on ClinicalTrials.gov

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