Expanded Access Resource e-Team
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.
Expanded Access to Invest…
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
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
NYU Langone Health
A resource understanding and navigating preapproval access, both in the U.S. and internationally.
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
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
MHRA
MHRA The supply of unlicensed medicinal products (“specials”); MHRA Guidance Note 14
IRDR Intractable and Rare…
IRDR Intractable and Rare Diseases Research – An overview of Compassionate Use Programs in the European Union member states.
FDA Home Expanded Access …
FDA Website providing information for Patients, Physicians and Industry on Compassionate Use
21st Century Cures Act
21ST CENTURY CURES ACT US Legislation
Expanded Access to Invest…
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
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
Expanded Access to Invest…
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
Expanded Access to Invest…
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
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
Expanded Access to Invest…
FDA Issues Revised Draft Guidance on Expanded Access to Investigational Drugs for Treatment Use
