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GUIDANCE DOCUMENT

Upper Facial Lines: Developing Botulinum Toxin Drug Products August 2014

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2014-D-0968
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of therapeutic biological products, specifically botulinum toxins, for the temporary improvement in the appearance of upper facial lines, such as glabellar lines or lateral canthal lines (LCLs). This guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs of botulinum toxin drug products to support approval for an upper facial lines indication. The information presented is intended to help sponsors plan clinical trials, design clinical protocols, and implement and appropriately monitor the conduct of clinical trials. This draft guidance is intended to serve as a focus for continued discussions among the Division of Dermatology and Dental Products, pharmaceutical sponsors, the academic community, and the public. Development plans should be discussed with the review division before embarking on trials to ensure that the clinical trial design meets defined objectives.

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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
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0968.

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