FDA Issues Guidance Titled "Nonprescription Sunscreen Drug Products—Content And Format Of Data Submissions To Support A GRASE Determination Under The Sunscreen Innovation Act"
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This draft guidance addresses FDA's current thinking on how it will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review...
United StatesFood, 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announced the availability of a draft guidance for industry titled
"Nonprescription Sunscreen Drug Products—Content and
Format of Data Submissions to Support a GRASE Determination Under
the Sunscreen Innovation Act." This draft guidance addresses
FDA's current thinking on how it will determine whether a
sponsor's submission of safety and efficacy data is
sufficiently complete to support a substantive review and
determination under the SIA that an active ingredient is or is not
GRASE for use in nonprescription sunscreen products.
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.
