Upper Facial Lines: Developing Botulinum Toxin Drug Products | Guideline Explorer

Description

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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Dermatology and Dental Products, pharmaceutical sponsors, the academic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.

Scope & Applicability

Product Classes

1

Botulinum Toxin Drug Products

Developing drug products for upper facial lines

Stakeholders

4

sponsor

responsible for justifying omission of studies

Pediatric population

Target population for dosing and safety assessment

Geriatric subjects

Population to be included in clinical trials

Independent committee of experts

Masked committee used for secondary endpoint adjudication

Regulatory Context

Attributes

2

Fitzpatrick skin types

This may include variable age, sex, and Fitzpatrick skin types

Clinically meaningful

A criterion used alongside statistical significance to evaluate sex differences.

Identified Hazards

Hazards

2

Inadvertent injection

Risk concern for topical drug products

Distant spread of toxin effect

A toxicity related to the pharmacologic effects of botulinum toxin

Related CFR Sections (2)

21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .Read full regulation →
21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →