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Zdrowie i gospodarka · 11.10.2016

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process." This guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees to provide recommendations on requests submitted under the SIA regarding nonprescription sunscreen active ingredients and the number of requests to be considered per meeting. The recommendations in this guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the- counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is not required to convene or submit requests to the Nonprescription Drugs

Source: Federal Register — Food and Drug AdministrationOpen original release →