Form FDA 2252 at a glance
What it is: Form FDA 2252 is the Transmittal of Annual Reports for Drugs and Biologics for Human Use (21 CFR 314.81).
Who signs: Enter the NAME and TITLE of the RESPONSIBLE OFFICIAL OR AGENT, and sign under 14. SIGNATURE.
This report is required by law (21 USC 355; 21 CFR 314.81). Failure to report can result in withdrawal of approval of the New Drug or Biologics License Application.
Complete a transmittal for each application for which an annual report is being submitted. If submitting electronically, submit one copy of the form and annual report to FDA. If submitting in paper, submit two copies of the transmittal form along with two copies of the annual report to FDA.
A filled-in Form FDA 2252 example: annual report for one NDA sent to CDER
How to fill out Form FDA 2252, box by box
Date Submitted
Enter the DATE SUBMITTED. Form Approved: OMB No. 0910-0001 Expiration Date: July 31, 2027.
1. Center (Select One)
For Center, select one: CDER or CBER.
2. Application Type and 3. Application Number
Enter the Application Type and the Application Number.
Report No. and FDA USE ONLY
Report No. (For FDA Use Only). Under FDA USE ONLY: NDA OR ANDA NUMBER and DATE OF RECEIPT.
4. Applicant and 5. Phone Number
Enter the APPLICANT and the PHONE NUMBER.
6. Type of Report (Check one)
For TYPE OF REPORT, check one: ANNUAL or OTHER.
7. Drug/Biologic Name
Enter the DRUG/BIOLOGIC NAME.
8. Other Application Numbers
If any part of the annual report applies to more than one application, list in item 8 all other applications to which such parts apply, each with its Application Type and Application Number.
9. Period Covered by Report
Enter the PERIOD COVERED BY REPORT: FROM and TO, each by YEAR and MONTH.
10a to 10c. NDA Report Information Required: Summary of Significant New Information, Distribution Data and Labeling
For NDA REPORT INFORMATION REQUIRED (See § 314.81 for description), enter the type of information attached under “Identification.” If you have nothing to report, enter None. Information in 10b and 10c is always required.
Identification is the Electronic file name or eCTD location or Volume No. (s) / Tab(s) / Page(s) of Report.
a. Under SUMMARY OF SIGNIFICANT NEW INFORMATION, enter the Identification.
b. DISTRIBUTION DATA: enter the Identification; Authorized Generic info is a box to check.
c. Under LABELING (Whether or not previously submitted), enter the Identification.
10d to 10f. Chemistry Manufacturing and Controls Changes, Nonclinical Laboratory Studies and Clinical Data
d. Under CHEMISTRY MANUFACTURING AND CONTROLS CHANGES, enter the Identification; SUPAC is a box to check.
e. Under NONCLINICAL LABORATORY STUDIES, enter the Identification.
f. Under CLINICAL DATA, enter the Identification.
10g to 10i. Status Reports of Open PMRs/PMCs, Other Open Postmarketing Studies and Log of Outstanding Regulatory Business
g. Under STATUS REPORTS OF OPEN PMRs/PMCs, enter the Identification; enter None if no open PMRs/PMCs to report.
h. Under STATUS OF OTHER OPEN POSTMARKETING STUDIES (e.g., voluntary studies, CMC commitment studies, and product stability studies), enter the Identification.
i. LOG OF OUTSTANDING REGULATORY BUSINESS is Optional.
11. BLA Report Information Required
For BLA REPORT INFORMATION REQUIRED (See § 601.70 for description), check the box under CONTENTS (Check box) for a. ANNUAL PROGRESS REPORTS OF POSTMARKETING STUDIES.
12. Typed Name and Title and 14. Signature
Enter the NAME and TITLE of the RESPONSIBLE OFFICIAL OR AGENT, and sign under 14. SIGNATURE.
13. Applicant's Return Address
Under APPLICANT'S RETURN ADDRESS, enter the Name of Sponsor / Applicant / Submitter, Address 1, Address 2, City, State and ZIP or Postal Code.
More rules for Form FDA 2252
Do not send your completed form to the PRA staff email address.
Sources
[1] Form FDA 2252 (03/26), Transmittal of Annual Reports for Drugs and Biologics for Human Use, U.S. Food and Drug Administration (the Official source link on this page).