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Data Sought on Unapproved OTC Sunscreens in Certain Dosage Forms
06/17/2011
 

Federal Register Advance notice of proposed rulemaking: FDA is asking sunscreen manufacturers and other interested parties to submit data on OTC sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. The agency is requesting data for spray dosage forms to resolve specific questions about both effectiveness and safety. It is also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective and not misbranded. Information should be submitted by 9/15. To view this advanced notice of proposed rulemaking, click here.

 
 
 
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