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Zdrowie i gospodarka · 23/11/2015

Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request." This draft guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of 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. We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn.

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