Phase IV Clinical Study means (i) any human clinical trial (other than a Phase I Clinical Study, Phase II Clinical Study or Phase III Clinical Study) in any country which is conducted on a product after Regulatory Approval of such product has been obtained from an appropriate Regulatory Authority, and includes clinical trials conducted voluntarily after Regulatory Approval for enhancing marketing or scientific knowledge of an approved indication or (ii) any REMS/RMP related study of a product after Regulatory Approval.
Phase IV Clinical Study means any post-marketing Approval clinical study, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drug’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time.
Phase IV Clinical Study. Phase IV Clinical Study means a human clinical study initiated in a country for the Licensed Product in an approved indication after receipt of Regulatory Approval for the Licensed Product for such indication in such country.
Examples of Phase IV Clinical Study in a sentence
In the event Genzyme experiences a Change of Control, Genzyme’s successor shall assume all of the rights and obligations of Genzyme as provided for in Section 13.3.1 above, including but not limited to: (a) Genzyme’s performance obligations under any Development Plan during a Development Term, and (b) Genzyme’s obligations with regards to any Phase IV Clinical Study of a Product for an Indication in the Genzyme Territory.
More Definitions of Phase IV Clinical Study
Phase IV Clinical Study means a clinical study of a Licensed Product commenced after FDA Regulatory Approval for such Licensed Product in order to (a) support Commercialization of the Product, or (b) fulfill a post-approval study commitment or undertaking imposed by the FDA.
Phase IV Clinical Study means a clinical study initiated after a Product has been granted Regulatory Approval in Japan, and which is aimed at strengthening the clinical evidence for such Product to be used in the Commercialization of such Product.
Phase IV Clinical Study means of such product for the purpose of establishing any clinical study conducted for such product after such product has received Regulatory Approval for marketing in a particular jurisdiction, including trials the principal purpose of which is to (a) continue testing such product to collect information about (i) its safety or efficacy to provide comprehensive data confirming the benefit-risk balance is positive to convert to a standard Regulatory Approval for marketing in broader or various populations, (ii) its long term safety and side effects associated with long term use, or (iii) its use in additional diseases or conditions other than those for which Regulatory Approval was previously granted where the product is likely to be used “off label” in the disease or condition as a result of a similar mechanism of action, (b) obtain or widen reimbursement coverage, (c) improve the product’s competitive position, or (d) improve the standard of care. For clarity, Phase IV Clinical Studies do not include investigator-initiated trials.
Phase IV Clinical Study means a post-marketing human clinical study for a Product with respect to any Indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.
Phase IV Clinical Study means a post‑marketing Clinical Study with respect to any Collaboration Product with respect to any indication that is commenced after the receipt of Regulatory Approval for such indication, including the trials referred to in 21 C.F.R. § 312.85, but excluding Post-Approval Studies. I.23
Phase IV Clinical Study. Phase IV Clinical Study means a human clinical study initiated in a country in an approved indication after receipt of Regulatory Approval for such indication in such country.
Phase IV Clinical Study means any Clinical Study in an indication for an Eisai Collaboration Product to be conducted after a Regulatory Approval in such indication which was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval or was otherwise conducted for any other purpose, including for medical observation or commercial purposes.