us-fda-guidance-2c714a7ed31842f43f792370be98e893•Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry
Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry
us-fda-guidance-2c714a7ed31842f43f792370be98e893Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for IndustryGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. Specifically, this guidance addresses the Agency’s current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. Development plans should be discussed with the review division before initiating trials to ensure that the trial design meets defined objectives.
Submit Comments
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:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
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