IND Annual Report definition

IND Annual Report means the report of progress of an IND-associated investigation that the Sponsor must submit to the FDA within sixty (60) days of the anniversary of the effective date of the IND (pursuant to 21 C.F.R. § 312.33).
View Source

Examples of IND Annual Report in a sentence

  • Notwithstanding the foregoing, Lilly shall not be obligated to provide Zosano copies of any Lilly Forteo® Regulatory Filings to the United States Food & Drug Administration for more than the past five (5) years and such copies shall be limited to the IND Annual Report, Developmental Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR).

  • With respect to clinical studies, a copy of the IND Annual Report will also fulfill this reporting obligation.

  • An SAE that occurs in a clinical investigation and that does not meet the requirements for expedited reporting, as set forth in Section 5.1 above, is subject to periodic reporting (e.g. US IND Annual Report, UK CTX renewal) by the Reporting Party.

  • Cempra agrees to provide Toyama a copy of the IND Annual Report and/or Periodic Adverse Drug Experience Report at the time of submission to the FDA.

Related to IND Annual Report

  • Annual Report means any Annual Report provided by the Issuer pursuant to, and as described in, Sections 3 and 4 of this Disclosure Certificate.

  • Quarterly Report has the meaning set forth in Section 5.02.

  • Operating Advisor Annual Report As defined in Section 3.29(d)(ii) of this Agreement.

  • Quarterly Statement means the quarterly statutory financial statement of any Insurance Subsidiary required to be filed with the insurance commissioner (or similar authority) of its jurisdiction of incorporation or, if no specific form is so required, in the form of financial statements permitted by such insurance commissioner (or such similar authority) to be used for filing quarterly statutory financial statements and shall contain the type of financial information permitted by such insurance commissioner (or such similar authority) to be disclosed therein, together with all exhibits or schedules filed therewith.

  • Financial Report means the annual financial report prepared under Chapter 2M of the Corporations Act for the Company and its controlled entities;