Post-Approval Study means a clinical study of a Licensed Product initiated in a country after receipt of Regulatory Approval for such Licensed Product in such country.
Post-Approval Study means all studies required as a condition to the grant of Regulatory Approval for the Licensed Product, such as confirmatory trials or PASS (post approval safety study).
Post-Approval Study means any human clinical study or other test or study with respect to a product for an indication that is not required in order to obtain or maintain Regulatory Approval for such product for such indication. For clarity, any human clinical study that is intended to expand the product labeling for such product shall be deemed not to be a Post Approval Study. Subject to the foregoing, Post Approval Study may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator or company sponsored or initiated studies and health economics studies.
Examples of Post-Approval Study in a sentence
Two (2) copies of each report, identified as an "ODE Lead PMA Post-Approval Study Report" in accordance with how the study is identified below and bearing the applicable PMA reference number, should be submitted to the address below.
Two (2) copies of each report, identified as an "ODE Lead PMA Post-Approval Study Report" or "OSB Lead PMA Post-Approval Study Report" in accordance with how the study is identified below and bearing the applicable PMA reference number, should be submitted to the address below.
Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study.
The reports should clearly be identified as Post-Approval Study Report.
Two copies for each study, identified as "PMA Post-Approval Study Report" and bearing the applicable PMA reference number, should be submitted to the address below.
More Definitions of Post-Approval Study
Post-Approval Study means a human clinical trial conducted after Regulatory Approval of the applicable Collaboration Product for the applicable indication has been obtained in the relevant country.
Post-Approval Study means any Clinical Study, patient registry or other data collection effort for the Product with respect to the Development Indication that is initiated in one or more countries after receipt of Regulatory Approval for such Development Indication and not to support or obtain an application for Regulatory Approval for another indication, which Clinical Study is required by the FDA, Health Canada or the EMA as a post-approval commitment or other condition to receiving Regulatory Approval for the Product in the Development Indication by the FDA, Health Canada or the EMA including but not limited to clinical experience trials, *Confidential Treatment Requested post-approval studies intended to evaluate clinical outcomes or the risk/benefits of the Product, paediatric studies (including Paediatric Plans) and studies that are required by a Regulatory Authority as post-approval commitments or other conditions to receiving Regulatory Approval for the Product in the Development Indication by the FDA, Health Canada or the EMA.
Post-Approval Study means a clinical study of the Covered Product Initiated in a country after receipt of Regulatory Approval for such Covered Product in such country.
Post-Approval Study means any human clinical study or other test or study with respect to a product for an indication that (a) is conducted solely in support of pricing or reimbursement for such product in a country or (b) is not required to obtain or maintain Regulatory Approval for such product for such indication (for clarity, any human clinical study that is intended to expand the Product Labeling for such product shall be a Clinical Study). Subject to the foregoing, Post Approval Studies may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies.
Post-Approval Study means any human clinical study, or other test or study with respect to a Licensed Product for an indication that (a) is conducted solely in support of pricing or reimbursement for such Licensed Product in a country or (b) is not required to obtain or maintain Initial Regulatory Approval for such Licensed Product for such indication and is conducted within the scope of the labeling for such Licensed Product (for clarity, any human clinical study that is intended to expand the labeling for a Licensed Product shall be a Clinical Trial and shall not be a Post Approval Study). Subject to the foregoing, Post Approval Studies may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies, and health economics studies. For clarity, Post Approval Studies shall not include any tests or studies that are required or recommended for a Licensed Product by the Regulatory Authorities as a condition to obtaining, or as a requirement of maintaining, an Initial Regulatory Approval for such Licensed Product for an indication.
Post-Approval Study has the meaning set forth in Section 5.2.
Post-Approval Study means a human clinical trial or other nonclinical studies, whether required by a Regulatory Authority or not, of a Licensed Product initiated in a country after receipt of Regulatory Approval for such Licensed Product in such country.