Expanded Access Program Solutions

The U.S. Food and Drug administration (FDA) defines Expanded Access as a potential pathway for a patient with a life-threatening condition, or serious disease or condition to gain access to an investigational medicinal product (drug, biologic or medical device) for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available.

Expanded Access (EA) is for unapproved drugs in advanced stages of clinical development where dosing and safety are more fully characterized.

There Are Three Types of Expanded Access

Individual IND, Including for Emergency Use

Expanded Access Protocol

Treatment IND or Treatment Protocol

In the United States, Expanded Access can be provided through multiple pathways: Individual IND, including emergency use, Intermediate Expanded Access Protocol (EAP), or Treatment IND. Early Access Care consultant services will provide guidance on options most suitable for client specifications. Our medical writers provide protocol development services to support all three.

There is regulatory precedent to support EAP in the presence or absence of efficacy data.

The FDA receives over 1,000 individual use applications per year and approves over 99% of those requests.

Often EAPs provide an opportunity to obtain additional safety data and further insights on the impact of the therapy on patients, ultimately informing the most appropriate use of the drug. This is especially true in rare and oncology EAPs. Our consultancy and medical writing services can assist pharmaceutical companies with options for wording suitable for any EAP.

Early Access Care provides expanded access program solutions customized to your needs.

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