IND Holder definition

IND Holder is defined as: A "Sponsor" as defined in 21 CFR Part 313.1(b) of an investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent thereto.
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IND Holder means the person or organization filing an IND with the FDA. The IND Holder agrees to comply with all FDA regulations and obligations relevant to experimental clinical trials (synonymous with the term “sponsor”. The IND holder for purposes of this agreement is the Collaborator.
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Examples of IND Holder in a sentence

  • Click “Add” to provide the IND number, Drug Name, and IND Holder in a pop‐up window.

  • Dr. Vedantham (Principal Investigator and IND Holder) will notify the NHLBI Project Officer; the DSMB Executive Secretary; the Washington University Human Research Protection Office; the FDA (fax (800) FDA-1078); Genentech Drug Safety (telephone (650) 225-2232, fax (650) 225-4630 or (650) 225-5288); the ATTRACT Steering Committee, and the Clinical Center investigators of any SAE that is a UP within 7 calendar days of first learning of the event.

  • The Medical Monitor is responsible for notifying the Principal Investigator (IND Holder) of any changes to the categorizations of serious adverse events and of any concerns regarding the frequency or type of adverse event(s).

  • Both have upstream transmission service providers (“TSPs”) that are owed money in connection with transmission services that MISO and ERCOT provided to the Debtor.

  • PennERAOverview or Pending Issue that May Impact Future Reviews: If IND Exempt: Include a note that states this, who did the exemption, and the date of the letter (if done by another Penn internal entity)Penn IND Holder: Should be checked when the University holds the IND.

  • PennERA• Overview or Pending Issue that May Impact Future Reviews: If IDE Exemption: Include a note that states this, who did the exemption, and the date of the letter (if done by another Penn internal entity)• Penn IND Holder: Should be checked when the University holds the IDE.

  • Phoenix, AZ 85054 480/301-8000 IND Holder: Study Co-Chairs:Statistician: Drug AvailabilitySupplied Investigational Agents: AZD1775Commercial Agents: Cytarabine (cytosine arabinoside or AraC) √ Study contributor(s) not responsible for patient care.

  • San Francisco, CA 94080Contact: Dr. Sanjay Gurunathan Contact: Dr. Don FrancisTel/Fax: 1-570-839-6185/0934 Tel/Fax: 1-650-228-7900/7901 Sponsor (Study IND Holder): Local Sponsor Liaison:Robert E.

  • Non-serious adverse events will be reported annually to FDA via an Annual Report (IND 119474) and to IRB via Continuing Review.The PD (aka Principle Investigator) must immediately report within 24 hours of knowledge of event to the Sponsor (ie, IND Holder, Eben Rosenthal, MD), any serious adverse event, whether or not considered related to study drug.

  • For example, as far as FDA is concerned, the sponsor is the IND Holder in the case that the study is under IND; and, an agreement for transferring responsibilities is documented with the IND Holder and the partner organization.

Related to IND Holder

  • Demand Holder has the meaning set forth in Section 3.02(a).

  • Preferred Holder means, with respect to a series of Preferred Units, a Record Holder of such series of Preferred Units.

  • FTR Holder means the PJM Member that has acquired and possesses an FTR.

  • Series B Holder means a Record Holder of the Series B Preferred Units.

  • Holder means a Person in whose name a Security is registered in the Security Register.

  • Warrant Holder means the holder of a Call Warrant.

  • Preferred Shareholder means any holder of Preferred Shares.

  • Excluded Holder means (a) any Person who at the time this Plan was adopted was the beneficial owner of 20% or more of the outstanding Common Stock; or (b) the Company, a Subsidiary or any Employee Benefit Plan of the Company or a Subsidiary or any trust holding Common Stock or other securities pursuant to the terms of an Employee Benefit Plan.

  • Designated Holder means the Holder of Note A-1.

  • Registered Holder means the Person in whose name a Note is registered on the Note Register on the applicable Record Date.

  • Existing Holder means a Broker-Dealer, or any such other Person that may be permitted by the Trust, that is listed as the holder of record of APS in the Share Books.

  • 10% Stockholder means the owner of stock (as determined under Code Section 424(d)) possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Corporation (or any Parent or Subsidiary).

  • Transferring Stockholder has the meaning assigned to such term in Section 3.4(a).

  • Transferring Shareholder has the meaning set forth in Section 5.2(a).

  • Electing Holder means any Holder of Registrable Securities that has returned a completed and signed Notice and Questionnaire to the Company in accordance with Section 3(a)(i) or 3(a)(ii) hereof.

  • Rights Holder means the holder of the Call Rights.

  • Eligible Stockholder means a person who has either (1) been a record holder of the shares of common stock of the Corporation used to satisfy the eligibility requirements in Section 3.2(d) continuously for the required three-year period or (2) provides to the Secretary of the Corporation, within the time period referred to in Section 3.2(e), evidence of continuous Ownership of such shares for such three-year period from one or more securities intermediaries.

  • Significant Stockholder means Allied Irish Banks, p.l.c., a limited liability company incorporated under the laws of Ireland having its registered office at Bankcentre, Ballsbridge, Dublin 4, Ireland, and any successor thereto.

  • Class B Stockholder means (i) the registered holder of a share of Class B Common Stock at the Effective Time and (ii) the initial registered holder of any shares of Class B Common Stock that are originally issued by the Corporation after the Effective Time.

  • Principal Stockholder means, collectively, (i) the Sponsor and (ii) any affiliate or successor of a person referenced in clauses (i) and (ii) of this definition.

  • right holder means a person or a legal entity that was previously granted or lawfully acquired a fishing right or which will be granted a right in the allocation process envisaged in this Policy.

  • Major Holder means with respect to any registration the Holder that, together with its Affiliates, includes the largest number of Registrable Securities in such registration.

  • Registered Shareholder means, as the context requires:

  • Potential Holder means any Broker-Dealer or any such other Person as may be permitted by the Corporation, including any Existing Holder, who may be interested in acquiring shares of AMPS (or, in the case of an Existing Holder, additional shares of AMPS).

  • Octopus Holder means a user of an Octopus who may be an AAVS Account Holder or who has linked his/her Octopus to an AAVS Account in the name of one of his/her family members or friends;