FFF Has FDA Approval for VariZIG Prepositioning

With FDA approval, FFF Enterprises is able to make prepositioned VariZIG available. VariZIG is a highly purified and specialized antibody preparation against the virus that causes chicken pox. Developed by the Canadian-based Cangene Corporation, VariZIG is available on a patient-specific basis under an FDA-approved Expanded Access Protocol and may be prepositioned at qualified sites.

Each preposition shipment includes five vials of VariZIG 125 IU and one patient-specific binder containing all study-related materials.

In order for a site to be qualified for prepositioning, a few simple steps are required:

• submit FDA form 1572 identifying the principal investigator and sub investigators.
• submit the Financial Disclosure Forms, their IRB approval and a signature on the Protocol Signature sheet.

Click here for more information on VariZIG protocol.

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