Guidance for Industry - Changes to an approved application for specified biotechnology and specified

Guidance for Industry - Changes to an approved application for specified biotechnology and specified

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Guidance for Industry Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products U.S. Department of Public Health Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research July 1997
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i TABLE OF CONTENTS Note: page numbering may vary for documents distributed electronically I. INTRODUCTION 1 II. CHANGES UNDER §§601.12(b) and 314.70(g)(1) 3 Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes). III. CHANGES UNDER §§601.12(c) and 314.70(g)(2) 4 Changes requiring supplement submission at least 30 days prior to distribution of the product made using the change. IV. CHANGES UNDER §§601.12(d) and 314.70(g)(3) 5 Changes to be described in an annual report (minor changes). V. COMPARABILITY PROTOCOLS UNDER §§601.12(e) 6 and 314.70(g)(4) VI. CHANGES UNDER §601.12(f) 7 Labeling changes. A. Changes under §601.12(f)(1) - Labeling changes requiring 7 supplement submission - FDA approval must be obtained before distribution of the product with the labeling change. B. Changes under §601.12(f)(2) - Labeling changes requiring 7 supplement submission - product with a labeling change may be distributed before FDA approval. C. Changes under §601.12(f)(3) - Labeling changes requiring 8 submission in an annual report.
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1 Guidance for Industry 1 : Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products I. INTRODUCTION Sections 314.70 and 601.12 of Title 21 of the Code of Federal Regulations (21 CFR 314.70 and 601.12) prescribe the requirements for the reporting to FDA of changes to the approved applications for licensed biological products and approved drug products. Under §§ 601.12 and 314.70(g), a change to a product, production process, quality controls, equipment, or facilities is required to be reported to FDA in: 1) a supplement requiring approval prior to distribution; 2) a supplement at least 30 days prior to distribution of the product made using the change; or 3) in an annual report, depending on its potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Before distributing a product made using a change, the regulations require applicants to demonstrate, through appropriate validation and/or other clinical or non-clinical laboratory studies, the lack of adverse effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to its safety or effectiveness. The three reporting categories for changes to an approved application are defined in § 601.12 and § 314.70(g): 1) those changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product, which require submission of a supplement and approval by FDA prior to distribution of the product made using the change;
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Guidance for Industry - Changes to an approved application for specified biotechnology and specified

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