Direct Biologics Compassionate Use Policy

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. Our compassionate use, also known as expanded access policy, consists of an expanded access program, single patient emergency IND (eIND), and single patient expanded access. The following is Direct Biologics’ expanded access, also known as compassionate use, policy for drugs that are intended to treat serious diseases.

General Criteria

Direct Biologics will evaluate and respond to each expanded access request that it receives on a case-by-case basis.  Criteria that will be used to evaluate such requests include the following:

  • There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the company’s clinical trials
  • There is a compelling medical and scientific rationale for the requested use
  • The potential benefit to the patient must outweigh the collective potential risks
  • There must be sufficient clinical data to identify an appropriate dose
  • The patient’s physician has determined that treating the patient with the investigational product is in the patient’s best interests

Contact Information

Please submit any questions or requests regarding expanded access to the following: expandedaccess@directbiologics.com

Request Procedures

Please submit sufficient supporting detail to enable us to evaluate the expanded access request.  Your request must include your contact information so that we may follow-up with you directly.

Anticipated Timing

We anticipate acknowledging receipt of any expanded access questions or requests within five (5) business days of receipt. Direct Biologics will evaluate and respond to each single patient expanded access request that it receives on a case-by-case basis. An expanded access protocol is also approved and enrolling at sites throughout the US. More information can be found on ClinicalTrials.gov

As authorized by the 21st Century Cures Act, Direct Biologics may revise this expanded access policy at any time.  Additionally, the posting of this policy by Direct Biologics shall not serve as a guarantee of access to any specific investigational drug by any individual patient.