W-L fishing for OTC anti-cholesterol agent
Warner-Lambert is introducing its Promega OTC fish oil supplement, which it said has been linked with lowering of cholesterol. Promega will be sold in one-piece, sealed soft gelatin capsules containing eicosapentrenoic acid 350 mg and docosahexaenoic acid 150 mg.
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The regulatory tools are for use in medical device development.
The US agency plans to hold a virtual workshop that will use breakout sessions to get stakeholder feedback on specific hurdles preventing more pediatric devices coming to market.