EAP Useful Links
This page is a consolidated set of links providing resources and information related to Expanded Access.
The content of this website is provided by GCSG’s EAP team and is to be used for guidance and planning purposes only. GCSG accepts no liability for the content of this website, or for the consequences of any actions taken on the basis of the information provided, unless that information is subsequently confirmed in writing. The intended recipient of this website is advised to verify the content of this website with your company’s regulatory representatives or the appropriate regulatory agencies. If you are not the intended recipient, you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited.
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The content of this website is provided by GCSG’s EAP team and is to be used for guidance and planning purposes only. GCSG accepts no liability for the content of this website, or for the consequences of any actions taken on the basis of the information provided, unless that information is subsequently confirmed in writing. The intended recipient of this website is advised to verify the content of this website with your company’s regulatory representatives or the appropriate regulatory agencies. If you are not the intended recipient, you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited.
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2 November 2022
Expanded Access to Invest...
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
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22 April 2019
Right to Try
Right to Try – this website provides information to patients and caregivers on the U.S. legislation ‘Right to Try Law’ with the intent to make it easy to understand
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22 April 2019
NYU Langone Health
A resource understanding and navigating preapproval access, both in the U.S. and internationally.
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22 April 2019
European Medicines Agency...
European Medicines Agency (EMEA)- Guideline on compassionate use of medicinal products, pursuant to article 83 of regulation (EC) No 726/200,19 July 2017
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22 April 2019
U.S. Food & Drug Administ...
U.S. Food & Drug Administration (FDA)-Expanded Access to Investigational Drugs for Treatment Use Q&A Guidance for the Industry
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22 April 2019
MHRA
MHRA The supply of unlicensed medicinal products (“specials”); MHRA Guidance Note 14
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22 April 2019
IRDR Intractable and Rare...
IRDR Intractable and Rare Diseases Research - An overview of Compassionate Use Programs in the European Union member states.
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22 April 2019
FDA Home Expanded Access ...
FDA Website providing information for Patients, Physicians and Industry on Compassionate Use
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18 April 2019
Abigall-Alliance
Abigail Alliance promotes better access to experimental drugs through expanded access and compassionate use programs.
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18 April 2019
Committee for Medicinal P...
CHMP - European Medicines Agency (EMA) fosters scientific excellence in the evaluation and supervision of medicines
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Reagan-Udall
Expanded Access Navigator
Expanded Access (EA) may be considered for patients who have exhausted their treatment options and are not eligible for, or able to participate in, a clinical trial.
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HPRA
HPRA's Information on exempt medicinal products and the Notification System for exempt medicinal products
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