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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Dermatology and Dental Products, pharmaceutical sponsors, the academic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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.