INITIAL INVESTIGATIONAL NEW DRUG APPLICATION. PROTECTION Investigational New Drug Application.
Name of Project, Initial IND Sponsor: Name of Investigator, MD Page 6 of 14 4. GENERAL INVESTIGATIONAL PLAN 4.1. Rationale The rationale for the drug or research study (the science behind why this is a good idea).. What is an Investigational New Drug Application (IND)? An IND is a request to FDA for authorization to administer an investigational drug (or biologic) to humans. Such authorization must be secured prior to interstate shipment of any new drug that is not lawfully marketed in the US as a drug for the purpose of conducting clinical investigations. Not all clinical investigations using.
Determination of IND Exemption for Marketed Drugs Investigational New Drug (IND) regulations (21CFR312) apply in human research studies that involve use of a drug (as defined in the . Food, Drug, and Cosmetic Act (FD&C Act)) in a clinical investigation (as defined in 21CFR312.3) unless otherwise exempt from IND requirements as described below. The following summary includes exemptions вЂ¦. FORM FDA 1571 (3/05) PREVIOUS EDITION IS OBSOLETE. PAGE 2 OF 2 . 12. CONTENTS OF APPLICATION . This application contains the following items: (Check all that apply).
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Investigational New Drug Application FDA Form 1571 The initial and each subsequent IND submission should be accompanied by Form FDA 1571 and must be submitted in triplicate (the original and 2 photocopies)..
5 В§312.3 21 CFR Ch. I (4вЂ“1вЂ“18 Edition) FDA will advise on the applicability of this part to a planned clinical inves-tigation. [52 FR 8831, Mar. 19, 1987, as amended at 61. Investigational New Drug Application Regulatory Sponsor: Name of the Sponsor-Investigator Department Name Address Phone Number вЂ“ Where possible, the quantitative composition of the investigational drug product, including any reasonable variations that may be expected during the investigational stage вЂ“ Packaging procedures as appropriate for the product вЂ“ Information sufficient вЂ¦. FORM FDA 1571 (3/05) PREVIOUS EDITION IS OBSOLETE. PAGE 2 OF 2 . 12. CONTENTS OF APPLICATION . This application contains the following items: (Check all that apply).
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