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Contents of a Complete Submission for the Evaluation of Proprietary Names Guidance for Industry - PharmaFacts
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Contents of a Complete Submission for the Evaluation of Proprietary Names Guidance for Industry

Contents of a Complete

Submission for the

Evaluation of

Proprietary Names Guidance for Industry

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

April 2016 Labeling

Revision 1

page1image4728

Contents of a Complete

Submission for the

Evaluation of Proprietary

Names Guidance for Industry

Additional copies are available from:
Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research

Food and Drug Administration
10903 New Hampshire Ave., Bldg. 71, Room 3128
Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER) Center for Drug Evaluation and Research (CBER)

April 2016 Labeling

Revision 1

page2image10600 page2image10760

 

I. II.

A. B. C. D. E.

III. IV.

A. B. C. D. E.

V. A.

B.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1

BACKGROUND ............................................................................................................... 2

Recommendations to Minimize Medication Errors.................................................................... 2

Medication-Use Systems ................................................................................................................ 4

Proprietary Name Confusion and Medication Errors................................................................ 4

FDA’s Approach to the Evaluation of Proposed Proprietary Names ....................................... 5

Regulatory Authority..................................................................................................................... 7

PDUFA IV GOAL DATES .............................................................................................. 8

CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF PROPOSED PROPRIETARY NAMES ......................................................................... 9

General Information ...................................................................................................................... 9

Proposed Proprietary Name ....................................................................................................... 10

Additional Information about the Product................................................................................ 11

Information about Product Dispensing and Delivery ............................................................... 14

Independent Assessments of Proprietary Name, Packaging, and/or Labeling ...................... 15

WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED PROPRIETARY NAME REVIEW .............................................................................. 15

Contains Nonbinding Recommendations

Drug Products, Including Biologics, That Are the Subject of an IND, NDA, or BLA — Paper Submission......................................................................................................................... 15 Drugs Products That Are the Subject of an ANDA — Paper Submission ............................. 16 Electronic Submissions ................................................................................................................ 16

C. GLOSSARY................................................................................................................................. 18

CLICK HERE FOR FULL GUIDANCE