Senate OTC Monograph Legislation Tracks House Bill On Exclusivity
Both bills allow 18-month market exclusivity periods for marketers of some products made available through additions or changes to OTC monograph, through which the majority of nonprescription drugs are made available in US. Senate bill in markup 31 October.
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Cosmetics Market In 2019: CBD, Microplastic And US Sunscreen Uncertainty Among Year’s Biggest Issues
The opportunity represented by cannabidiol, and the uncertain future for commonly used sunscreen active ingredients in the US and microplastic in the EU, were issues of high interest among cosmetics industry stakeholders in 2019.
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.