federal_register: 2016-24233

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-24233 Head Lice Infestation: Developing Drugs for Topical Treatment; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Head Lice Infestation: Developing Drugs for Topical Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. 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. This guidance finalizes the draft guidance of the same name issued on December 15, 2015. 2016-10-06 2016 10 https://www.federalregister.gov/documents/2016/10/06/2016-24233/head-lice-infestation-developing-drugs-for-topical-treatment-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-10-06/pdf/2016-24233.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Head Lice Infestation: Developing Drugs for Topical Treatment." The purpose of this guidance is to assist sponsors in the clinical...  

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