ARTICLE
11 December 2015

FDA Issues Guidance Titled "Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process"

JD
Jones Day

Contributor

Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
In the November 23, 2015, Federal Register, FDA announced the availability of a draft guidance for industry titled "Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process."
United States Food, Drugs, Healthcare, Life Sciences

As discussed above, in the November 23, 2015, Federal Register, FDA announced the availability of a draft guidance for industry titled "Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process." This draft guidance explains the process by which FDA intends to carry out the section of the FD&C Act, as amended by the SIA, that governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to: (i) 586A requests submitted under the FD&C Act, and (ii) pending requests that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is GRASE for use under specified conditions and should be included in the OTC sunscreen drug monograph. Comments are due January 22, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

See More Popular Content From

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More