Guidance for Industry - changes to an approved application - biological products

Guidance for Industry - changes to an approved application - biological products

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Guidance for Industry Changes to an Approved Application: Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research July 1997
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i TABLE OF CONTENTS Note: Page numbering may vary for documents distributed electronically I. INTRODUCTION 01 II. CHANGES UNDER §601.12(b) 03 Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes). III. CHANGES UNDER §601.12(c) 05 Changes requiring supplement submission at least 30 days prior to distribution of the product made using the change. IV. CHANGES UNDER §601.12(d) 07 Changes to be described in an annual report (minor changes). V. COMPARABILITY PROTOCOLS UNDER §601.12(e) 09 VI. CHANGES UNDER §601.12(f) 09 Labeling changes. A. Changes under §601.12(f)(1) - Labeling changes requiring 10 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 10 supplement submission - product with a labeling change may be distributed before FDA approval. C. Changes under §601.12(f)(3) - Labeling changes requiring 11 submission in an annual report.
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1 GUIDANCE FOR INDUSTRY 1 : CHANGES TO AN APPROVED APPLICATION: BIOLOGICAL PRODUCTS I. INTRODUCTION Frequently, a licensed applicant determines that it is appropriate to make a change in the product, labeling, production process, quality controls, equipment, facilities, or responsible personnel established in the approved license application(s). Section 601.12 of Title 21 of the Code of Federal Regulations (21 CFR 601.12) prescribes the requirements for reporting such changes for licensed biological products to FDA. Under §601.12, a change to a product, production process, quality controls, equipment, facilities, or responsible personnel 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) an annual report, depending on its potential to have an adverse effect on the identity, strength, quality, purity, or potency of the biological product as they may relate to the safety or effectiveness of the product. Before distributing a product made using a change, applicants are required 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 as they may relate to the safety or effectiveness of the product. The three reporting categories for changes to an approved application are defined in § 601.12: 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 1
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Guidance for Industry - changes to an approved application - biological products

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