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INSTRUCTIONS FOR COMPLETION OF FORM FDA 2252 – TRANSMITTAL OF ANNUAL

REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE

(The field numbers below correspond to the numbered areas on Form FDA 2252)

NOTE: Form FDA 2252 should accompany all annual report submissions for NDAs, ANDAs, and BLAs. (21

CFR 314.81(b)(2), 601.70(b), and 601.12(d)) and may accompany other reports .

Field 1: Identify the appropriate application type, New Drug Application (NDA), Abbreviated New Drug

Application (ANDA), or Biologics License Application (BLA), to which the annual report submission applies.

Field 2: Enter the application number.

Fields 3 and 4:

When U.S. applicants are submitting the report on their own behalf: Enter the name and phone number of the

applicant in these fields.

When authorized U.S. agents are submitting the report on behalf of an applicant: Enter the name and phone

number of the U.S. agent in Field 3 and Field 4. Note that an authorized U.S. agent is required if the applicant

does not reside or have a place of business within the United States (21 CFR 314.50(a)(5)). For biologic

products, the name of applicant in Field 3 is the name of the person or legal entity to whom the license has

been issued.

Field 5: Enter the type of report being submitted.

Field 6: Enter the proprietary and established names for the product.

Field 7: Enter additional NDA, ANDA, or BLA number(s) if any part of the report applies to more than one

application number. Use the continuation page as needed.

Field 8: Enter the beginning and end dates that encompass the reporting period covered by the report.

Field 9: NDA/ANDA REPORT INFORMATION REQUIRED

Under the IDENTIFICATION column, enter the type of information included in the report, the electronic file

name or volume number(s) if a paper submission, and the pages of the report the designated information

can be found on. If you have nothing to report for the type of information listed in the table, enter ‘none’ under

IDENTIFICATION. See 21 CFR 314.81(b)(2) for the full details of each type of information.

a. Summary of Significant New Information: A brief summary of significant new information, relative to

the previous year’s report, that might affect the safety, effectiveness, or labeling of the drug product.

b. Distribution Data: Information about the quantity of the drug product distributed under the approved

application, including that distributed to distributors. Under TYPE OF INFORMATION, indicate if

distribution data for an authorized generic drug product is included. Also include in the body of the

report information about the authorized generic described under 21 CFR 314.81(b)(2)(ii)(b).

c. Labeling: Provide the currently used professional labeling, patient brochures or package inserts, and a

representative sample of the package (e.g., carton, container) labels.

d. Chemistry, Manufacturing, and Controls Changes: Reports of studies or tests involving the physical

or chemical properties of the drug as described under 21 CFR 314.81(b)(2)(iv) and a full description of

the manufacturing and controls changes that do not require a supplemental application under 21 CFR

314.70 (b) and (c).

e. Nonclinical Laboratory Studies: Copies of unpublished reports and summaries of published reports

of new toxicological finding in animal studies and in vitro studies concerning the ingredients of the drug

product (21 CFR 314.81(b)(2)(v)).

FORM FDA 2252 SUPPLEMENT (11/14) – FORM INSTRUCTIONS

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Instructions For Completion Of Form Fda 2252 - Transmittal Of Annual Reports For Drugs And Biologics For Human Use