FDA Guidance on Developing Drugs for Treating Lice Infestation

FDA has released a guidance on “Head Lice Infestation: Developing Drugs for Topical Treatment” to assist sponsors in the clinical development of such drugs. Specifically, the document gives the agency’s current thinking on the overall development program and clinical trial designs, and is intended to 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,” the guidance says. The document does not contain information on general issues of statistical analysis or clinical trial design, which are addressed in the ICH guidances E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials.