Phase IV Clinical Trials definition

Phase IV Clinical Trials means product support clinical trials of a Collaboration Product commenced after receipt of Regulatory Approval in the indication for which such trial is being conducted.

Phase IV Clinical Trials means certain post-marketing studies to delineate additional information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after receipt of regulatory approval for a product in the indication for which such trial is being conducted.

Phase IV Clinical Trials means a human clinical trial for a Product commenced after receipt of FDA Approval in the United States and that is conducted within the parameters of the FDA Approval for such Product. Phase IV Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such Product and post-marketing surveillance studies.

Examples of Phase IV Clinical Trials in a sentence

• Following the Effective Date, Titan shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and Braeburn and Titan shall cooperate in good faith during the Transition Period to ensure that all Phase IV Clinical Trials are transferred in compliance with all Laws and regulations.

• For clarity, any Clinical Trials included in “Commercialization Costs” (e.g. post-marketing and Phase IV Clinical Trials) are excluded from “Development Costs.” Development Costs specifically exclude any costs or expenses of a Party or its Affiliates to the extent caused by such Party or its Affiliate’s breach of this Agreement.

• Within five Business Days of the Effective Date, Braeburn shall notify the clinical investigative sites and investigators participating in the Phase IV Clinical Trials (collectively, the “ Investigators”) regarding the termination of Braeburn’s responsibility for the applicable Phase IV Clinical Trial and the assumption of sponsorship and control of such Phase IV Clinical Trial by Titan.

• Phase IV Clinical Trials - Is There a Better Way to Use It?Even after testing a new medicine on thousands of patients, usually new questions arise as the studies progress.

• Serious infections were observed in 9% of patients receiving Humira in the study and included dental caries, rotavirus gastroenteritis, and varicella.In pJIA Study II, non-serious allergic reactions were observed in 6% of patients and included intermittent urticarial and rash, which were all mild in severity.Additional Adverse Reactions from Post-Marketing Surveillance or Phase IV Clinical Trials Adverse events have been reported during post-approval use of Humira.

More Definitions of Phase IV Clinical Trials

Phase IV Clinical Trials means product support clinical trials of a Product commenced after receipt of Regulatory Approval in the United States for such Product. These trials shall be considered a part of Clinical Work.

Phase IV Clinical Trials means post-marketing studies to delineate additional information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after receipt of regulatory approval for a product in the indication for which such trial is being conducted.

Phase IV Clinical Trials means trials conducted after the Product is marketed for treatment of RA to provide additional details about the Product's efficacy or safety profile. Such trials may be mandatory at the direction of regulatory authorities, or they may be voluntary to collect additional patient information.

Phase IV Clinical Trials means post-marketing studies to delineate additional information about a pharmaceutical product’s risks and benefits, and optimal use, commenced after receipt of Regulatory Approval for a Product in the indication for which such trial was conducted.

Phase IV Clinical Trials means a human clinical trial, or other test or study, of a compound or product for an indication that is commenced after receipt of the initial Regulatory Approval for such indication in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the compound or product for such indication (and which may include investigator sponsored clinical trials), including a clinical trial conducted due to the request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval, that would satisfy the requirements of 21 C.F.R. 312.85.

Phase IV Clinical Trials means product support clinical trials, including but not limited to trials including new drug delivery systems, of a Collaboration Product with an approved label claim that is commenced after receipt of Regulatory Approval in the country where such trial is being conducted. These trials shall be considered a part of Commercialization.

Phase IV Clinical Trials means those clinical trials, including safety surveillance studies, conducted under an IND which are agreed upon by the Commercial Lead and a Regulatory Authority as a condition of approval or maintenance of approval of a Drug Approval Application for a Collaboration Product, as the case may be, other than patient registries of other than a passive, non-interventional nature.