Form Fda 1571 Instructions - Investigational New Drug Application (Ind) printable pdf download

INSTRUCTIONS FOR FILLING OUT FORM FDA 1571 – INVESTIGATIONAL

NEW DRUG APPLICATION (IND)

(The field numbers below correspond to the numbered boxes on the Form FDA 1571)

Field 1: NAME OF SPONSOR

The sponsor is the person who takes responsibility for and initiates a clinical investigation. The sponsor may

be an individual, pharmaceutical company, governmental agency, academic institution, private organization

or other organization (21 CFR 312.3(b)). A Sponsor-Investigator is an individual who both initiates and

conducts a clinical investigation and under whose immediate direction the investigational drug is being

administered or dispensed (21 CFR 312.3(b)). For administrative reasons, only one individual should be

designated as sponsor.

If a pharmaceutical company will be supplying the drug, but will not itself be submitting the IND, the company

is not the sponsor.

Field 2: DATE OF SUBMISSION

Enter the date the submission is being submitted to the FDA. The date entered should match the date of the

cover letter for the submission.

Fields 3–4: SPONSOR ADDRESS AND TELEPHONE NUMBER.

Provide the address and telephone number of the sponsor identified in field 1 (21 CFR 312.23(a)(1)(i)). If this

address is a post office box number, a street address should also be provided on line 2.

The telephone number is the number where the sponsor is usually available during normal working hours.

Field 5: NAME(S) of DRUG

For name(s) of drug (21 CFR 312.23(a)(1)(i)), list the generic name(s) and trade name, if available. Also,

provide the dosage form(s), and the unique ingredient identifier (UNII) term and code for active substances (if

applicable). Use the Continuation Page if additional space is needed.

Field 6A: IND NUMBER

Provide the IND number if it was previously assigned. If an IND number has not been assigned, leave the field

blank. For IND numbers less than six digits, the IND number should be preceded using zeros (i.e., for IND

12345 enter 012345).

Field 6B: IND TYPE

Select Commercial IND if the product under investigation is intended to be commercialized at a later date.

(21 CFR 312.320)

Select Research IND if the product under investigation is not intended to be commercialized at a later date.

Research INDs are generally sponsored by individual investigators, academic institutions and non-profit

entities. May include INDs for emergency use and expanded access. (21 CFR 312.305 and 312.310)

Field 7: (PROPOSED) INDICATION FOR USE

The proposed indication should be provided. Indicate if the proposed indication is for a rare disease

(prevalence <200,000 U.S. patients). If the sponsor for the submission is the holder of the Orphan Designation

Number, select “Yes” and provide the six-digit Orphan Designation Number in the appropriate field; if

not, select “No.”

Use the Continuation Page if there are more than one proposed indications for use by adding one indication

per entry and providing rare disease/Orphan Drug Designation information for each entry, as applicable.

FORM FDA 1571 SUPPLEMENT (7/17) – FORM INSTRUCTIONS

Page 1 of 5

PSC Publishing Services (301) 443-6740 EF

Form Fda 1571 Instructions - Investigational New Drug Application (Ind)