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[DOCX File]GUIDANCE Applicability of FDA Regulations
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Use of a drug or medical device when the purpose is to obtain basic physiological information rather than gathering data for submission to (or inspection by) the FDA. Examples: Participants will be given a FDA-approved statin drug after consuming citrus juice, and blood samples will be collected during the next 12 hours to examine the effect on ...
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[DOC File]Guidance for Industry - Food and Drug Administration
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FDA Object Identifier NCI Concept Identifier Description 2.16.840.1.113883.3.26.1.1 C102834 Type 1: Convenience Kit of Co-Package C102835 Type 2: Prefilled Drug Delivery Device/System (syringe ...
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[DOCX File]Regulatory Binder Checklist - National Institutes of Health
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Jul 17, 2015 · Regulatory Binder Checklist Subject: To provide an organizational framework for filing paper versions of essential study documents (or referencing location of an electronically stored file) Keywords: Regulatory Binder Checklist, clinical trials, grant, grantee, form, template, primary investigator, PI, study, nccih, nih Last modified by
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DMF template - Food and Drug Administration
Submission Type: [Enter the applicable submission type (e.g., administrative amendment, quality amendment, LOA, annual report) as listed in the DMF Submission and Amendment Types table on …
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[DOC File]Content and Format of an Investigational Device Exemption ...
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To avoid delays in the FDA review process, it is recommended that the complete Investigation Plan be incorporated into the initial submission of the IDE application. IDE Guidance Memorandum #D89-1, “Review of IDEs for Feasibility Studies, May 17, 1989 (D89-1”, …
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[DOCX File]Claim of Exemption from FDA Investigational New Drug (IND ...
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Claim of Exemption from FDA Investigational New Drug (IND) Regulatory Requirements. Principal Investigator: Study Title: Drug/Drug Product: Under FDA regulations, research that involves use of a drug other than the use of a marketed drug in the course of medical practice, must have an IND, unless the study meets one of the exemptions from the IND requirement [21 CFR 312.2(b)].
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Attachment E CDRH Final Guidance Cover Sheet
For those submission types for which an eCopy is required, an eCopy (with a signed cover letter and an adequate eCopy statement) will serve as one of the required number of copies for the applicable submission types. FDA will accept additional eCopies in lieu of additional paper copies as long as at least one paper copy is submitted along with ...
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[DOCX File]STATEMENT OF COMPLIANCE
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This clinical trial protocol template is a suggested format for Phase 2 and 3 clinical trials funded by the National Institutes of Health (NIH) that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application.
types of fda submissions

[DOCX File]Expanded Access for Unapproved Drugs and Biologics
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An IND is an application to the FDA for permission to test a drug to determine if it is safe and effective. The process is governed by 21CFR 312. ... FDA submission and IRB review are required. ... types of regulatory submissions to the FDA to obtain the IND: (1) An expanded access protocol submitted as a protocol amendment to an EXISTING IND ...
types of fda filings

Attachment E CDRH Final Guidance Cover Sheet
For recommendations that apply to Pre-Subs for specific submission types, please see Appendix 1: Recommendations for Specific Types of Pre-Subs. Recommended Information for Pre-Sub Packages . In general, a Pre-Sub should be a clear and concise document that includes the relevant background information and specific questions for FDA.
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Fda drug submission types