New Guidance Documents - Prophylaxis of Inhalational Anthrax/ MUsT Studies and the OTC Monograph/ OTC Sunscreens/ Acne Vulgaris

New Guidance Documents for Industry

1. Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax - Guidance for Industry

The purpose of this guidance is to assist sponsors in the development of new drugs to be administered to people who have or may have inhaled Bacillus anthracis spores, but who have not yet manifested clinical evidence of disease, to prevent the development of inhalational anthrax.  This guidance clarifies that drugs for the prophylaxis of inhalational anthrax are to be considered for approval under the animal rule regulations because human efficacy trials are not ethical or feasible.

2. Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph (OTC): Study Elements and Considerations - Guidance for Industry

The FDA has been generally encouraging manufacturers to collect data on the potential risks of a topical drug when used according to the maximum limits of the product’s instructions, what we call Maximal Usage Trials or MUsT studies. The FDA has issued a draft guidance that, when finalized, will provide recommendations to industry on how to design and conduct MUsT studies for topical active ingredients that are under consideration for inclusion in an OTC monograph. Read our blog to learn more.

3. Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application - Guidance for Industry

This guidance describes FDA’s enforcement approach with respect to OTC sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC sunscreen drug products without an approved application.  OTC sunscreens are not yet the subject of an effective final monograph, and we continue to evaluate information relevant to defining conditions under which such products are generally recognized as safe and effective (GRASE) and not misbranded. 

4. Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment - Guidance for Industry

The purpose of this guidance is to provide recommendations to industry for establishing clinical effectiveness of drugs for the treatment of acne vulgaris (acne). The recommendations in this guidance are based on the FDA’s assessment of issues raised in the review of clinical trials for acne.