Indication

Example Definitions of "Indication"
Indication. The term "Indication" shall mean a distinct type of disease or medical condition in humans to which a Product is directed and eventually approved in the Field. To distinguish one Indication from another Indication, the two Indications have to be (i) listed in two different blocks of the Tenth Revision of the International Classifications of Diseases and Related Health Problems of 2010 (as a way of example, any neoplasm under C15 is in a different block from any neoplasm under block C16, whereas... C15.0 and C15.1 belong to the same block), and (ii) developed under a separate Phase II Clinical Trial and Phase III Clinical Trial. View More
Indication. (a) a cancerous condition resulting from a separate and distinct tumor type or (b) any non-cancerous condition, in each case of (a) or (b) for any size patient population and in each case of (a) or (b) subject to the following: (i) subtypes of the same disease or condition are not additional Indications; (ii) different symptom domains or domains of impairment of the same disease or condition are not additional Indications; (iii) the approved or potential use of any product for such disease in... different combinations or co-therapies of treatments are not additional Indications (e.g., monotherapy vs. add-on or combination therapy with another agent in the same disease); (iv) treatment, prevention or cure of a disease or disease subtype each are not additional Indications; (v) the approved or potential use of any product for such disease in a different line of treatment or a different temporal position in a treatment algorithm for the same disease or condition are not additional Indications (e.g., first line vs. second line therapy in the same disease or condition); and (vi) treatment of the same disease or condition with any product in an expanded, narrowed, modified or additional patient population or for a different defined subset of patients with such disease or condition (or, with respect to cancer, cancer of the same tumor type) (e.g., elderly, or genetically defined patients subgroups (e.g., 17 p deletion CLL patients), etc.). View More
Indication. An application for a label indicating the applicable drug for an initial patient population in each case that requires a clinical trial for Regulatory Approval.
Indication. The diagnosis of a generally acknowledged disease or medical condition in humans as identified in an IND, NDA, or BLA for a Product. For clarity, the treatment of the same medical condition in variants of a single disease shall be deemed hereunder as one and the same.
All Definitions