Form FDA 2252 PDF Details

The FDA Form 2252, central to the regulatory field of pharmaceuticals and biologics, serves as a critical tool for companies to submit their annual reports to the Food and Drug Administration (FDA). As mandated by law, this submission is obligatory for maintaining the approval status of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or Biologics License Applications (BLAs). The form, which requires detailed information including drug or biologic names, applicant contact information, types of reports, and specific data on distribution, labeling changes, and updates on manufacturing processes, ensures that the FDA stays informed about significant changes and ongoing post-marketing commitments. Notably, the form allows for the reporting of both NDA and BLA-related information, highlighting the dual focus on both pharmaceuticals and biologics. Failure to comply with this submission requirement can result in severe consequences, such as withdrawal of the approved drug or biologic from the market. The structured process outlined on the form, including the submission of accompanying documents, underscores the importance of accurate and timely reporting by license holders to continuously monitor the safety, efficacy, and quality of medicines available to the public.

QuestionAnswer
Form NameForm FDA 2252
Form Length1 pages
Fillable?No
Fillable fields0
Avg. time to fill out15 sec
Other namesform no fda 2252, how to fill form 2252, form 2252, fda form 2252 fda

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TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS

DATE SUBMITTED

 

Form Approved: OMB No. 0910-0001

 

 

 

AND BIOLOGICS FOR HUMAN USE

 

 

 

Expiration Date: May 31, 2008

 

 

 

 

(21 CFR 314.81)

 

 

 

See OMB Statement on Reverse.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOTE: This report is required by law (21 USC 355; 21 CFR 314.81). Failure to report can result

 

1. NDA, ANDA, OR BLA NUMBER

 

 

 

in withdrawal of approval of the New Drug or Biologics License Application.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

N

 

 

 

 

 

 

 

 

 

 

 

 

INSTRUCTIONS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. Report No. (FDA Complete)

 

 

Complete a transmittal form for each application for which an annual report is being

 

 

 

 

 

 

 

 

 

 

 

submitted. Retain the carbon copy labeled "applicant." Submit the remaining copies of the

Y-

 

 

 

 

 

 

 

 

 

transmittal form 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 all other

Reference NDA and Y, or BLA numbers

 

 

(entered on Acknowledgement Copy) in any

applications to which such parts apply.

 

 

 

 

 

 

subsequent correspondence regarding report.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. APPLICANT

 

 

PHONE NUMBER

 

 

 

5. TYPE OF REPORT (Check one)

 

 

 

 

 

 

(

)

 

 

 

 

 

ANNUAL

OTHER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. DRUG/BIOLOGIC NAME

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6. OTHER NDA OR BLA NUMBERS (List all numbers if any part of report applies to more than one number.)

 

7. PERIOD COVERED BY REPORT

 

 

 

 

 

 

 

 

 

 

 

FROM

 

TO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

YEAR

 

MONTH

YEAR

 

MONTH

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NDA REPORT INFORMATION REQUIRED (See § 314.81 for description)

 

 

 

 

 

 

 

 

8.

(Enter type of information attached under "Identification." If you have nothing to report, enter None.)

 

 

 

 

 

 

 

(INFORMATION IN "8b" AND "8c" IS ALWAYS REQUIRED.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TYPE OF INFORMATION

 

 

IDENTIFICATION (Volume No.(s) / Tab(s) / Page(s) of Report)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a. SUMMARY OF

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SIGNIFICANT NEW INFORMATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b.

DISTRIBUTION DATA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 POST-MARKETING STUDY COMMENTMENTS

h.STATUS OF OTHER POSTMARKETING

STUDIES (e.g., voluntary studies, CMC commitment studies, and product stability studies)

i.LOG OF OUTSTANDING REGULATORY BUSINESS (Optional)

9.

BLA REPORT INFORMATION REQUIRED (See § 601.70 for description)

 

 

 

 

 

TYPE OF INFORMATION

 

 

 

CONTENTS (Check box)

 

 

 

 

 

 

 

 

 

 

a. ANNUAL PROGRESS REPORTS OF

 

 

 

 

 

 

 

 

 

POSTMARKETING STUDIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT

 

 

 

 

FDA USE ONLY

 

 

 

 

 

 

 

 

 

 

 

 

10. NDA OR ANDA NUMBER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

N

 

 

 

 

 

SIGNATURE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11. DATE OF RECEIPT

 

 

 

 

 

 

 

 

 

 

APPLICANTS RETURN ADDRESS (Type within the window envelope tic marks)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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FORM FDA 2252 (6/05)

PREVIOUS EDITION IS OBSOLETE.

PSC MEDIA ARTS (301) 443-1090 EF

Public reporting burden for this collection of information is estimated to average 5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Food and Drug AdminIstration

CDER, HFD-336

7520 Standish Place

Rockville, MD 20855-2737

Food and Drug Administration

CBER, HFM-99

1401 Rockville Pike, Suite 200N

Rockville, MD 20852-1448

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control

number.

FORM FDA 2252 (6/05)

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how to fill form 2252 writing process detailed (portion 1)

2. When the last part is completed, you have to put in the required particulars in a SUMMARY OF, SIGNIFICANT NEW INFORMATION, b DISTRIBUTION DATA, 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 COMMENTMENTS, h STATUS OF OTHER POSTMARKETING, STUDIES eg voluntary studies CMC, and LOG OF OUTSTANDING REGULATORY so you're able to proceed to the next step.

how to fill form 2252 completion process clarified (step 2)

Always be really careful when filling in f CLINICAL DATA and g STATUS REPORTS OF POSTMARKETING, as this is the part where most people make mistakes.

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how to fill form 2252 completion process shown (portion 3)

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