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Royal DSM NV

www.dsm.com

Latest From Royal DSM NV

Omega-3 Firms Parse Amarin's Fair Trade Complaint Into Tariff Act Questions

Attorneys for DSM, Pharmavite and Nordic Naturals pose two questions they say the Supreme Court is being asked in Amarin's request for a fair trade investigation. One is whether under Tariff Act, Federal Circuit lacks jurisdiction to review an ITC decision not to investigate? The second concerns an attempt for private enforcement of FDA regulations framed as a complaint to force an investigation under the Tariff Act.

Dietary Supplements Legal Issues

Amarin's Asking ITC To Do FDA's Job, Federal Attorneys Tell Supreme Court

In petition to Supreme Court, Amarin does not assert it makes any fair trade claim "that could be proved without establishing" an FDCA violation, nor does it dispute that its "claims are ultimately premised on allegations that the FDCA was violated," say DoJ solicitor general and ITC counsel.

Legal Issues Dietary Supplements

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
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