Expanded Access & Unlicensed Medicine

Customized Solutions for Unique Needs 

Caligor Rx is licensed to supply investigational medicines through a variety of named patient and special access programs in the US and Europe.  Our expansive network of doctors, hospitals and advocacy groups, along with our regulatory expertise and relationships, make Caligor Rx the ideal partner to meet your requirements.

We design customized programs tailored to a variety of specialized needs, including pre-launch, product termination, and distribution of unlicensed medications in orphan indications.

Many countries allow patients with serious or life-threatening conditions to access unlicensed medicines in situations where other options are unavailable.

• Expanded Access Programs (EAPs)– In the United States, investigational new drugs are made available under certain circumstances to treat a serious disease or condition experienced by patients who cannot participate in a controlled clinical trial or for whom no good alternative treatment is available. Under FDA regulations and policies, these Expanded Access Programs (EAPs) can be conducted under Emergency Use Protocol, a Treatment IND, a Single Patient Use or a Parallel Track mechanism.
  

• Named Patient Programs (NPP)/Unlicensed Medicines– Outside of the United States, the member states of the European Union (under the auspices of the European Medicines Agency) have special access programs where an unmet medical need exists. These programs enable physicians and hospitals to provide pre-approval access to a specific “named” patient prior to marketing approval in the patient’s home country. In the UK, such programs are made available under the Medicines and Healthcare products Regulatory Agency (MHRA).
  

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Bridging the gap in

pharmaceutical supply.

Expanded Access