ContraFect Corporation’s Expanded Access Policy
The following is ContraFect’s policy for evaluating and responding to requests for individual patient expanded access to its investigational drug exebacase for serious diseases, in accordance with section 561A of the Federal Food, Drug, and Cosmetic Act.
All requests for individual patient expanded access to investigational drugs manufactured by or for ContraFect should be sent via e-mail to ExpandedAccessUse@contrafect.com
Requests for individual patient expanded access to ContraFect investigational products must come from the patient’s treating physician, who must be appropriately licensed. The request should explain how the criteria described in 21 C.F.R. 312.305 & 312.310 are met. The requesting physician must agree to conduct expanded access treatment in accordance with applicable regulatory requirements, and comply with all other safety, monitoring, administrative, and patient consent requirements defined by ContraFect.
GENERAL CRITERIA TO EVALUATE AND RESPOND TO EXPANDED ACCESS REQUESTS
ContraFect will evaluate and respond to requests for individual patient expanded access on a case-by-case basis based on factors that include whether the requirements of 21 C.F.R. 312.305 & 312.310 are met; whether providing the product will jeopardize regulatory approval or clinical development of the product; and clinical considerations.
TIMING OF ACKNOWLEDGEMENT
ContraFect anticipates that it will acknowledge receipt of any expanded access requests within 7 business days of receipt.
If ContraFect decides to make its investigational product candidates available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.
As authorized by section 561A, ContraFect may revise this expanded access policy at any time. Additionally, the posting of this policy by ContraFect shall not serve as a guarantee of access to any specific investigational drug by any individual patient.