Phase 4 Study definition

Phase 4 Study means any study or data collection effort in respect to any Product for a particular Indication that is initiated after receipt of Regulatory Approval for the Product for such Indication.

Phase 4 Study means a post-marketing human clinical study for a Licensed 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 4 Study means any study or data collection effort in respect to any Product for a particular Indication that is initiated after receipt of Regulatory Approval for such Product for such Indication.

Examples of Phase 4 Study in a sentence

• Strakan shall provide its comments to Aptalis within fifteen (15) days after receiving a single Protocol for a Phase 4 Study and thirty (30) days after receiving multiple Protocols for a Phase 4 Study, and shall notify Aptalis within such time period(s) whether or not it approves the respective Protocol(s), provided that such approval will not be unreasonably withheld, conditioned or delayed.

• Aptalis shall provide its comments to Strakan within fifteen (15) days after receiving a single Protocol for a Phase 4 Study and thirty (30) days after receiving multiple Protocols for a Phase 4 Study, and shall notify Strakan within such time period(s) whether or not it approves the respective Protocol(s), provided that such approval will not be unreasonably withheld, conditioned or delayed.

• Aptalis shall prepare a design and protocol(s) for any Phase 4 Study it or its sublicensees may propose (collectively, regardless of the preparer, including those prepared under Section 4.2.2, a “Protocol”) to carry out, and will submit each such Protocol to Strakan for its review, comment and approval.

• During the Term, Strakan will submit each Protocol for a Phase 4 Study it or its licensees may propose to carry out in respect of the Product outside of the Territory to Aptalis for its review, comment and approval.

• Statistical Analysis Plan for Clinical Studies: H9X-JE-GBGF: A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication inPatients with Type 2 Diabetes 12.

More Definitions of Phase 4 Study

Phase 4 Study means a clinical study which is carried out after Commercialization of the Product (i.e., a study that is not carried out at the request of any Regulatory Authority or in connection with obtaining or maintaining any Regulatory Approval).

Phase 4 Study means any human clinical study of Product conducted after Product receives the first Regulatory Approval, but not required by the applicable Regulatory Agency as a condition of such Regulatory Approval.

Phase 4 Study means a human clinical trial of a compound or product in patients commenced after receipt of Regulatory Approval for such compound or product, which clinical trial is conducted within the parameters of such Regulatory Approval, including clinical trials required or requested by any Regulatory Authority as a condition of, or in connection with, obtaining such Regulatory Approval of such compound or product, provided, a “Phase 4 Study” may also include clinical trials to gather additional information regarding such compound’s or product’s potential risks, medical or pharmacoeconomic benefits, justification and descriptions for other indications of such compound or product, data to be included in compendial listings, optimal use, dose, route and schedule of administration, epidemiological studies, modeling and pharmacoeconomic studies.

Phase 4 Study means any Phase 4 Required Study or any Phase 4 Optional Study.

Phase 4 Study means any clinical trial of a Licensed Product conducted after receipt of Marketing Authorization in the approved indication, which is required to maintain such Marketing Authorization or otherwise useful for Commercializing such Licensed Product.

Phase 4 Study means (a) a human clinical trial for a Licensed Product for an Indication that is required by a Regulatory Authority as a condition of (but is not completed before) obtaining the initial Regulatory Approval for such Licensed Product for such Indication and (b) any trial, test or study that is required or requested by a Regulatory Authority as a condition of maintaining the initial Regulatory Approval for a Licensed Product for an Indication, excluding any Post Approval Study.

Phase 4 Study means a human clinical trial, conducted following Marketing Authorization for the Licensed Product in a particular indication, the principal purpose of which is to monitor the long term efficacy and safety in patients being studied with the Licensed Product in such indication or a related indication (including drug-drug interaction, dose-response, schedule of administration and/or duration, use of the drug in other patient populations or other stages of the disease, safety studies and/or other studies designed to support use under the approved indication) as further described in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States.