68 - What is the Canadian specific definition for "off label" regarding reprints? FDA in it's draft guidance Good Reprint Pratices refer to indications and treatment regimens. PAAB code section 3.2 indicates material "must be consistent" with the indications, dosage regimens, efficacy and safety information information in the Cdn TMA. If the article is not specifically listed in the TMA, does it automatically be become "off label"?

  • PAAB regards "off label" as a claim that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). A study that is not listed in the TMA is not automatically "off-label". We would need to look at the content of the study (e.g study population, dosages used, approved indication) in order to determine whether these parameters are in-line with the TMA or "off-label". ( See PAAB Code section 3.1)