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Royal DSM NV

www.dsm.com

Latest From Royal DSM NV

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."

OTC Drugs FDA

FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension

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.

OTC Drugs Cosmetics

Proposed Sunscreen Rule, Final MUsT Guidance Jumpstart Next-Gen UV Filter Discussions

CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.

OTC Drugs Drug Approval Standards

Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

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