Form Fda 2252 – Fill Out and Use This PDF

FDA Form 2252 is an important document in the world of health and wellness. Its purpose is to provide accurate, up-to-date information to stakeholders regarding the design, development, and production of products used for healthcare purposes. It includes a wide array of vital details, from laboratory costs and personnel requirements, to machinery management regulations. Additionally, it defines critical documents like Material Safety Data Sheets (MSDS) and clinical study reports. The oversight this format provides offers invaluable reassurance that products are manufactured and maintained according to pre-established regulatory standards—perfectly underscoring how paramount such characteristics are within this essentially life-sustaining practice.

Form Fda 2252 PDF Details

In order to ship prescription drugs and medical devices in the United States, you need to have a Form FDA 2252. This form is used to declare that your products are safe for transport, and it includes information about the product, such as its name and ingredients. The form also includes contact info for the shipper and recipient, as well as an emergency number in case of problems during transit. If you're shipping prescription drugs or medical devices, be sure to familiarize yourself with Form FDA 2252 so that your products arrive safely at their destination.

Question	Answer
Form Name	Form Fda 2252
Form Length	2 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	30 sec
Other names	form 2252, fda form 2252 fda, form fda 2252, fda 2252 form

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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.

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

YEAR

MONTH

YEAR

MONTH

NDA REPORT INFORMATION REQUIRED (See § 314.81 for description)

(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

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
				FDA USE ONLY
			10. NDA OR ANDA NUMBER

			N
SIGNATURE			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.

3. Your next stage is going to be easy - fill in all of the empty fields in SIGNATURE, APPLICANTS RETURN ADDRESS Type, NDA OR ANDA NUMBER, DATE OF RECEIPT, FORM FDA, PREVIOUS EDITION IS OBSOLETE, and PSC Media Arts in order to complete this segment.

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

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Form Fda 2252 – Fill Out and Use This PDF

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