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[DOC File]Investigational New Drug (IND) Submission checklist
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If utilizing a drug that is currently subject to a manufacturer’s IND, or marketing application, refer to that IND or application or Drug Master File (if appropriate) to prevent duplicating information that are already available to FDA. Include a Letter of Authorization from the other sponsor permitting FDA to use their information for this IND.
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[DOC File]IND Application Template:
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Initial Investigational New Drug Application - (provide name of investigational new drug or biological product) ... Investigational drug labeling requirements. ... HINT: If your research involves the use of a product that is FDA-approved for marketing and the IND Application will include the current FDA-approved Package Insert, this section of ...
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[DOC File]IND Responsibilities - Research
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Sponsor-investigators have extensive reporting requirements under FDA regulations. New protocol. 21 CFR 312.30a. Once the IND has been approved by the FDA, the sponsor-investigator must submit a new protocol for any study not contained in the IND application. The …
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INITIAL INVESTIGATIONAL NEW DRUG APPLICATION
INITIAL INVESTIGATIONAL NEW DRUG APPLICATION . IND Title (if title being used) Serial 000 (Note to User: This template is intended for ‘simple’ INDs where commercially marketed drugs are being evaluated by sponsor-investigators.
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[DOC File]IND Safety Reports: Notification Requirements and Format
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Requirements for written IND Safety Reports. The sponsor shall notify the FDA and all participating investigators in a written IND Safety Report of: Any human adverse event that is (i) Associated with the use of the drug or study treatment(s) and (ii) both Serious and Unexpected.
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[DOC File]Formatting Requirements for IND applications
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Requirements for Submitting an IND Application. All University-based IND applications and all documents relevant to such applications shall be submitted to the FDA . via. the University’s Office for Investigator-Sponsored IND and IDE Support (O3IS).
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[DOC File]TRANSFER OF SPONSOR IND OBLIGATIONS
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Under 21 CFR Part 312 Investigational New Drug (IND) Application. ... Other 21 CFR 312 Sponsor Requirements. ... 21 CFR 312.32 IND Safety Reports Submission of written IND safety reports to FDA and all participating investigators, as referenced in 21 CFR 312.32. XYZ Co. to FDA.
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[DOC File]INITIAL INVESTIGATIONAL NEW DRUG APPLICATION
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Rather than insert the Form FDA 1572 and CV within this document, we recommend that you assemble the IND after separately printing this IND document and the Form FDA 1572 and CV. To ensure that the TOC on Page 3 reflects the true number of pages in the IND, format the page number on the following CMC page to reflect the additional pages in the ...
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FDA Forms 1571 and 3674 - ReGARDD
The FDA form 3674 is a document that must accompany all FDA IND initial submissions (and some types of amendments). It is a signed statement from the sponsor/investigator that they will comply with clinicaltrials.gov requirements concerning their investigation.
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[DOC File]Formatting Requirements for IND applications
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Requirements for completing the 1571 . All initial sponsor-investigator IND and IDE applications and all subsequent submissions to a FDA-accepted IND or IDE application shall incorporate the address of the O3IS as the address of the Sponsor on the accompanying FDA Form 1571; i.e.: This address will be noted in box 3 and box 20 of the 1571.
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Fda ind application requirements