Transmittal Of Annual Reports For Drugs And Biologics For Human Use
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1
2DATE SUBMITTED
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS
Form Approved: OMB No. 0910-0001
Expiration Date: December 31, 2017
AND BIOLOGICS FOR HUMAN USE
(21 CFR 314.81)
See OMB Statement on Reverse Side.
1. Application Type
NOTE: 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.
2. Application Number
INSTRUCTIONS
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 No. (For
report to FDA. If submitting in paper, submit two copies of the transmittal form
FDA Use Only)
along with two copies of the annual report to FDA.
APPLICANT NOTE
If any part of the annual report applies to more than one application, list in item 7
Reference NDA and Y, or BLA numbers (entered
on Acknowledgement Copy) in any subsequent
all other applications to which such parts apply.
correspondence regarding report.
3. APPLICANT
4. PHONE NUMBER
5. TYPE OF REPORT (Check one)
(
)
ANNUAL
OTHER
6. DRUG/BIOLOGIC NAME
7. OTHER NDA OR BLA NUMBERS (List all numbers if any part of report applies to more than one number.)
8. PERIOD COVERED BY REPORT
FROM
TO
YEAR
MONTH
YEAR
MONTH
Add Continuation Page
§
NDA REPORT INFORMATION REQUIRED (See
314.81 for description)
(Enter type of information attached under “Identifi cation.” If you have nothing to report, enter None.)
9.
(INFORMATION IN “9b” AND “9c” IS ALWAYS REQUIRED.)
IDENTIFICATION (Electronic fi le name or eCTD location or
TYPE OF INFORMATION
Volume No.(s) / Tab(s) / Page(s) of Report)
a. SUMMARY OF SIGNIFICANT NEW
INFORMATION
Authorized
b. DISTRIBUTION DATA
Generic info
c. LABELING (Whether or not
previously submitted)
d. CHEMISTRY MANUFACTURING AND
CONTROLS CHANGES
SUPAC
e. NONCLINICAL LABORATORY STUDIES
f. CLINICAL DATA
g. STATUS REPORTS OF POSTMARKETING
STUDY COMMITMENTS
h. STATUS OF OTHER POSTMARKETING
STUDIES (e.g.,voluntary studies,CMC
commitment studies, and product stability studies)
i. LOG OF OUTSTANDING REGULATORY
BUSINESS (Optional)
BLA REPORT INFORMATION REQUIRED (See
10.
§
601.70 for description)
TYPE OF INFORMATION
CONTENTS (Check box)
a. ANNUAL PROGRESS REPORTS OF POSTMARKETING STUDIES
13. SIGNATURE
11. TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT
Sign
12. APPLICANT’S RETURN ADDRESS
FDA USE ONLY
Name of Sponsor / Applicant / Submitter
NDA OR ANDA NUMBER
Address 1
DATE OF RECEIPT
Address 2
City
State
ZIP or Postal Code
FORM FDA 2252 (12/14)
Previous Edition Is Obsolete
Page 1 of
EF
2
PSC Publishing Services (301) 443-6740
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