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announced the availability of a draft guidance for industry titled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 This draft guidance explains the process by which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The recommendations in this draft guidance apply to: (i) 586A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.
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