IND Holder definition
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.
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.
Examples of IND Holder in a sentence
When all appropriate review and approval has occurred the IND Holder shall submit the protocol to the FDA.
To achieve these objectives, The Research Organisation and ▇▇▇▇▇ agree to perform the following study-related activities Scope of Work by Party: • St. Jude Children’s Research Hospital (the Research Organization): • IND Holder and Study Sponsor • Regulatory Preparation, Submissions, and Reporting per Guidelines.
IND Holder is defined as: A “Sponsor” as defined in 21 C.F.R. Section 312.3(b) of an investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent thereto.