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INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR

ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE

(The field numbers below correspond to the numbered boxes on the Form FDA 356h)

NOTE: Please submit a new Form FDA 356h with each submission. Complete the pages of the form

sequentially using continuation pages as needed. If continuation pages are not needed, click on the

‘Remove Continuation Page’ button at top/bottom of form.

Field 1: 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 2-6: APPLICANT INFORMATION

This section should include the name, street address, telephone and facsimile numbers of the person or legal

entity submitting the application. For biologic products, the name of applicant in Field 2 is the name of the

person or legal entity to whom the license will be issued. Enter the U.S. license number, if previously issued,

in the appropriate field. Enter the name, street address, and telephone number of the person or legal entity

authorized to represent a non-U.S. applicant in Field 6.

Fields 7-15: PRODUCT DESCRIPTION

This section should include all of the information necessary to identify the product that is the subject of this

application or submission.

Field 7: Provide the six-digit application number. For application numbers less than six-digits, the application

number should be preceded using zeros (i.e., for NDA 12345 enter 012345).

Field 8: Provide the four-digit supplement number with preceding zeros for supplement numbers that are less

than four-digits (i.e., for Supplement 1 enter 0001).

Field 15: For original and efficacy supplemental applications only (including resubmissions to these application

types), provide the indication(s) proposed within the application. Indicate if the proposed indication is for a

rare disease (prevalence <200,000 U.S. patients). Indicate if the product proposed within the application

(i.e. not the reference listed drug for an ANDA) has an FDA Orphan Drug Designation and if so; provide the

six-digit Orphan Designation number. If the submission is not an original application or efficacy supplement,

select ‘No’ in response to ‘Is this indication for a rare disease?’ 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. If continuation pages are not needed, click on the

‘Remove Continuation Page’ button at top/bottom of form.

Fields 16-31: APPLICATION INFORMATION

Fields 16-18: Identify the appropriate application type.

Field 19: If the application is a 351(k) BLA, provide the name of the biological reference product that is the

basis for the application and the holder of the licensed application.

Field 20: If the application is an ANDA or 505(b)(2) NDA, provide the name of the reference listed drug

(ANDA) or listed drug(s) (505(b)(2) NDA) that is/are the basis for the application, the application number(s)

for the listed drug(s), and indicate what type(s) of patent certification or statement described under 21 CFR

314.50(i) is provided within the application.

Field 21: Select one of the submission types listed or specify the type of submission under “Other” if otherwise

not listed. See also 21 CFR 314.3(b).

Original: An application for which FDA has never issued an approval letter;

Labeling Supplement: A supplemental application for labeling changes to an approved product as

described under 21 CFR 314.70 and 21 CFR 601.12 that does not otherwise qualify as another type of

supplement (e.g., Efficacy, CMC, REMS);

FORM FDA 356h SUPPLEMENT (3/14) – FORM INSTRUCTIONS

Page 1 of 3

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Instructions For Filling Out Form Fda 356h - Application To Market A New Or Abbreviated New Drug Or Biologic For Human Use

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