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Drug Master Files (DMFs) > FDA IND, NDA, ANDA, or Drug Master File Binders

Home Drugs Development & Approval Process (Drugs) Forms & Submission Requirements

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FDA IND, NDA, ANDA, or Drug Master File Binders REQUIRED SPECIFICATIONS FOR FDAs IND, NDA, ANDA, DRUG MASTER FILE BINDERS
Binders (covers) can be ordered on line from the U.S. Government Printing Office (GPO) Web site: http://bookstore.gpo.gov/1 by searching for the appropriate form or by calling 202-512-1800 to speak with a GPO customer service representative. If you have any questions or need additional information regarding the use of the binders , please contact FDA via druginfo@fda.hhs.gov. Binders that are not ordered from the GPO must meet the following requirements:

POLYETHYLENE BINDERS Front (flat size) - 248 x 292mm (9-3/4 x 11-1/2") Back (flat size) - 248 x 305mm (9-3/4 x 12") (size includes 13 mm (1/2") lip at top) Must be high impact linear plastic (matte finish or similar) - Must be able to withstand temperatures up to 150 degrees - Material should have a surface smooth enough to allow printing with a complete bonding of ink to the surface after a minimum of one hour drying time - Should be free from streaks, blisters, scratches and mottling Binder weight MUST be .023-.025 gauge - Ink color MUST be BLACK Polyethylene Binders include FDA FDA FDA FDA Form 2626 - Blue - NDA ARCHIVAL BINDER Form 2675 - Red - IND ARCHIVAL BINDER Form 3316 - Red - DRUG MASTER FILE BINDER Form 3316a - Blue - DRUG MASTER FILE ARCHIVAL BINDER

PAPER BINDERS Front (flat size) - 267 x 292mm (10-1/2 x 11-1/2") Back (flat size) - 267 x 305mm (10-1/2 x 12") (size includes 13mm (1/2") lip at top) Binder MUST be of 11-point plate rope stock of extra heavy weight - Ink color MUST be BLACK - Maroon binder ink color MUST be WHITE Paper Binders include FDA FDA FDA FDA FDA FDA FDA FDA FDA Form 2626a - Red - NDA CHEMISTRY BINDER Form 2626b - Yellow - NDA PHARMACOLOGY BINDER Form 2626c - Orange - NDA PHARMACOKINETIC BINDER Form 2626d - White - NDA MICROBIOLOGY BINDER Form 2626e - Tan - NDA CLINICAL DATA BINDER Form 2626f - Green - NDA STATISTICS BINDER Form 2626h - Maroon - NDA FIELD SUBMISSION CHEMISTRY BINDER Form 2675a - Green - IND CHEMISTRY BINDER Form 2675b - Orange - IND MICROBIOLOGY BINDER

PRINTING - Required on front folder in a clear, sharp, permanent-type print in BLACK ink - Permanent adhesive labels may be used in a clear, sharp print - Printing must withstand a "Scotch Tape Test" which consists of pressing a strip of "Scotch" tape firmly on the printed area and removing - There should be NO transfer of the printed area on the tape www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073080.htm 1/5

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Drug Master Files (DMFs) > FDA IND, NDA, ANDA, or Drug Master File Binders

BINDING - POLYETHYLENE binders (front and back) MUST contain an internal (HIDDEN) hinge formed in the material by heat and pressure - Hinge should extend along the entire left-hand binding edge of the binder and be of a depth to provide a clean straight fold free from wrinkle when created or folded on the hinge Hinge holes should be reinforced with metal eyelets and suitable for accommodating an ACCO-type fastener allowing for expansion - Outside binder surfaces MUST be smooth with NO exposed hinges or fastener PAPER binders (front and back) MUST have 2 hinge holes scored along the entire left-hand binding edge and must be of a depth to provide a clean straight fold free from wrinkle when creased or folded on the score Hinge holes should be reinforced and suitable for accommodating an ACCO-type fastener allowing for expansion Round corner the inside edge of tab on back folder and outside edges of the front and back folders on polyethylene and paper binders Finished margins MUST conform with binder sizes indicated above Below is a cover sample for FDA Form 2626, 2626a thru h - NDA Applications Below is a cover sample for FDA Form 2675, 2675a and b - IND Appications Below is a cover sample for FDA Form 3316, 3316a - Drug Master Files SPECIFICATIONS Page 2 SAMPLE COVER - FORM FDA 2626 (series a-h) NOTE: Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders. VOLUME __________________

NEW DRUG APPLICATION NDA No. _________

NAME OF APPLICANT

NAME OF NEW DRUG

SECTION NAME (* see below) This submission: VOL.______OF______VOLS. -------------------Listed below are FDA New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) binders identical to sample above. Section cover name is ONLY difference.

www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073080.htm

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Drug Master Files (DMFs) > FDA IND, NDA, ANDA, or Drug Master File Binders

* FORM # COLOR 2626 Blue 2626a Red 2626b Yellow 2626c Orange 2626d White 2626e Tan 2626f Green 2626h Maroon SPECIFICATIONS Page 3

INK Black Black Black Black Black Black Black White

SECTION COVER NAME ARCHIVAL COPY NDA CHEMISTRY NDA PHARMACOLOGY NDA PHARMACOKINETIC NDA MICROBIOLOGY NDA CLINICAL DATA NDA STATISTICS NDA FIELD SUBMISSION CHEMISTRY

SAMPLE COVER - FORM FDA 2675 (series a-b) Note: Sample is smaller in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders. VOLUME __________________

NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION FOR A NEW DRUG

IND. NO.__________

SPONSOR

NAME OF DRUG (* see below)

This submission: VOL._____OF______VOLS. -------------------Listed below are FDA Investigational New Drug (IND) binders identical to sample above. Section cover name is ONLY difference. * FORM # COLOR INK COVER DRUG NAME 2675 Red Black IND NAME OF DRUG 2675a Green Black IND NAME OF DRUG 2675b Orange Black IND NAME OF DRUG

www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073080.htm

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Drug Master Files (DMFs) > FDA IND, NDA, ANDA, or Drug Master File Binders

SPECIFICATIONS Page 4 SAMPLE COVER - FDA FORM 3316 NOTE: Sample is SMALLER in print (FONT) size than actual cover. Printing MUST match lay-out of previously submitted section binders. VOLUME __________________

DRUG MASTER FILE NO. ________

NAME OF APPLICANT (* see below)

TYPE:

This submission: VOL.______OF______VOLS. -------------------Listed below are FDA Drug Master File (DMF) binders identical to sample above. File # and Type will be ONLY difference. * FORM # COLOR INK COVER NAME 3316 Red Black Drug Master File 3316a Blue Black Drug Master File

Page Last Updated: 01/11/2013 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Email FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals
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Drug Master Files (DMFs) > FDA IND, NDA, ANDA, or Drug Master File Binders

Links on this page:

1. http://bookstore.gpo.gov/

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