Section I: Description of American Regent Expanded Access
The American Regent Expanded Access program provides Physicians an opportunity to request access to an American Regent unapproved investigational product for a patient who suffers from a serious disease or condition where no other treatment option in that indication for that patient population exists.
All requests must be submitted using the Expanded Access form. All requests will be reviewed by American Regent medical personnel. Should the request be approved, the requestor must enter into an Expanded Access Agreement with American Regent.
American Regent, Inc. cannot approve Expanded Access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
For approved requests, American Regent will provide the investigational product at no charge to the requestor for a duration and frequency determined by the company. The requestor is responsible for reporting any safety issues associated with the use of the investigational product to American Regent. American Regent is not accountable for securing local ethics committee approval for use of such investigational product.
Section II: Overview of process and anticipated timelines:
Physicians must complete the Expanded Access form and submit it via this web site using the SUBMIT button at the bottom of the form.
American Regent medical personnel will review the form for completeness and make a decision on the request.
If a decision is made not to provide access to an investigational product, American Regent will notify the requestor within 10 business days from receipt of the completed form.
If a decision is made to provide access to an investigational product, the requestor will be notified by American Regent with instructions for executing the Expanded Access Agreement within 10 business days from receipt of the completed form.
Upon full execution of the Expanded Access Agreement, drug shipment coordination with the Physician’s office will be scheduled.
Section III: Criteria
- Patient suffers from a serious disease or condition, where there is an unmet medical need that cannot be met by existing products
- Patient is ineligible or unable to participate in any ongoing clinical study of the investigational product
- Investigational product is under active development (Phase 2 and beyond)
- The benefit-risk profile of the drug in the indication and the patient population is positive
- There are adequate supplies of investigational product to meet the needs of an EAP without impairing the clinical trial development program
- The expanded access use of the investigational product will not interfere with development of the drug
- There are plans to file and commercialize the drug in the region
- The use of the investigational product in an expanded access protocol is compliant with local rules and regulations
- There is a good understanding of the likely indication to be approved
- The use of the investigational product will discontinue as soon as practical when approval of the drug is achieved in the country
- The program will be equitably available to the population of the region in question
Section IV: Instructions for Expanded Access form
Please do not submit any patient protected information
1. Complete all questions relating to Patient Eligibility criteria.
2. Complete the Physician Section.
3. Please include your medical opinion about the medical benefit the investigational product may provide to the patient.
All incomplete and/or illegible applications will be returned to the Physician for completion.
PLEASE DO NOT INCLUDE ANY PATIENT MEDICAL INFORMATION/RECORDS WITH THIS APPLICATION.