IND Sponsor definition

IND Sponsor means Dr. Xxxx Xxxxxxx, Associate Professor-Surgery, (Neurosurgery) Duke University Medical Center.
Sample 1

Examples of IND Sponsor in a sentence

  • In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations.

  • Accordingly, NHLBI and the IND Sponsor hereby grant Company a right to cross-reference relevant data within IND Application 13967 for purposes of developing and commercializing Company’s products, including without limitation the Test Article.

  • The IND Sponsor will be determined after contract award, the “Responsible Party” for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov).

  • The NHLBI acknowledges that the Company has provided the IND Sponsor with a letter of cross-reference to all pertinent regulatory filings (including IND 13335) sponsored by the Company for the limited purpose of IND Application 13967.

  • In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. $12.150(b)(1), or other applicable regulations in the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in ***Confidential Treatment Requested PHS ICT-CRADA Case Ref.

  • The Company acknowledges that it has received from the IND Sponsor a letter granting the FDA permission to cross-reference the IND filed by the Sponsor for this Clinical Trial for other regulatory submissions provided by Company.

  • The Company acknowledges that the IND Sponsor has submitted the Protocol with the U.S. FDA to the already active IND #13967.

  • In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. $12.150(b)(1), or other applicable regulations.

  • Genta is the IND Sponsor and is directing the clinical development program.

  • The IND Sponsor agrees to provide to the other Party copies of all Adverse Drug Experience reports concurrently with their submission to the FDA, including copies of any warning letters or other information affecting the safety and/or well-being of human subjects in research conducted under this CRADA.

Related to IND Sponsor

  • Project Sponsor means an eligible governmental agency receiving program funds pursuant to an approved application.

  • Prototype Sponsor Means the entity specified on the Adoption Agreement which sponsors this prototype plan.

  • Non-Lead Sponsor means the Note A-2 Holder in its capacity as the sponsor with respect to the Non-Lead Securitization Note in connection with the Non-Lead Securitization.

  • Sponsor shall have the meaning given in the Recitals hereto.

  • Underlier Sponsor means S&P Dow Jones Indices LLC.

  • MPCA means the Minnesota Pollution Control Agency or Minnesota Pollution Control Agency staff as delegated by the Minnesota Pollution Control Agency.

  • Retaining Sponsor CREFI, acting as retaining sponsor as such term is defined under Rule 2 of Regulation RR.

  • Financial Sponsor means any Person, including any Subsidiary of such Person, whose principal business activity is acquiring, holding, and selling investments (including controlling interests) in otherwise unrelated companies that each are distinct legal entities with separate management, books and records and bank accounts, whose operations are not integrated with one another and whose financial condition and creditworthiness are independent of the other companies so owned by such Person.

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Asset Management Plan means a plan created by the department and approved by the state transportation commission or a plan created by a local road agency and approved by the local road agency's governing body that includes provisions for asset inventory, performance goals, risk of failure analysis, anticipated revenues and expenses, performance outcomes, and coordination with other infrastructure owners.

  • Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;