Need Private Meeting For Sunscreen MUsT Details? Just Ask, FDA Says
"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."
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Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.
FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
FDA final guidance on MUsTs for topically applied ingredients for OTC drug monograph affirms draft, not incorporating changes pushed by industry. CHPA says FDA’s MUsT study published recently finding sunscreen actives penetrate skin to bloodstream at higher levels than previously believed demonstrates "value" of test method.