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GUIDANCE DOCUMENT

Public Availability of Labeling Changes in "Changes Being Effected" Supplements September 2006

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2006-D-0038
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance announces to holders of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), who intend to submit a “Changes Being Effected” supplement (CBE supplement) to make a postapproval labeling change, that FDA will make labeling revisions identified in a CBE supplement publicly available upon receipt of the supplement by FDA. This guidance does not have any bearing on supplements that relate to chemistry, manufacturing, and controls changes.
 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2006-D-0038.

 
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