US law and regulations require that unapproved drug products be investigated and ultimately approved in compliance with the Food & Drug Administration's Investigational New Drug Application (IND) requirements. Provectus is currently authorized to test Rose Bengal in our PV-10 and PH-10 formulations in clinical studies following protocols compliant with the IND process. Provectus cautions that it is unlawful and potentially harmful for individuals to attempt to use Rose Bengal for treatment of cancer or dermatologic disorders outside the proscribed IND process. At this time the PV-10 formulation may be available on a "compassionate use" basis in the United States and Australia.
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