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  • Daiichi Sankyo Open Care Program Form

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Tion must be completed and signed by the patient. Licensed Practitioner Section must be completed and signed by the practitioner (no stamps). The practitioner must complete the Prescription Section of the application, or include an original prescription written for a 12 month supply of the name brand medication. Attach a copy of the most recent federal tax return for the household. If the patient does not file taxes, please attach other proof of annual household income (W-2/1099, social security.

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Confirm patient's current disease or condition qualifies for expanded access. You must determine that your patient has either a serious or immediately life-threatening disease or condition and there is no available comparable or satisfactory alternative available for the patient.

Named-Patient Programs (NPPs) Whereas CUPs (and Expanded Access Programs in the US) allow physicians to offer the drug to several patients who fulfill the criteria, NPPs are limited to the requested named patient or patients only.

Expanded access is different than the off-label use of a drug [2]. Off-label use involves the prescription of an approved drug for a condition other than that indicated in the formal approval, whereas expanded access allows for the use of a drug that has not yet been granted formal approval.

Expanded Access Program (EAP) Daiichi Sankyo provides an option to give access to investigational products for reasons that include “compassionate use.” This program allows access to investigational products for these patients.

What is Expanded Access? Expanded Access (EA), also referred to as Compassionate Use, is a pathway for patients with a serious and life-threatening disease to access an investigational product (IP) that is not yet approved by the FDA. EA is an option for patients who do not qualify to participate in a clinical trial.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232