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Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.
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Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.
Amazon's Basic Care OTC brand SKUs have doubled units since last year's launch and is putting great pricing pressure on private label competitors, says a Jefferies analyst. But a private label consultant says the e-commerce giant's threat to competitors in the consumer health market is over-hyped.
By setting up Pfizer Consumer Healthcare to have sales and earnings results reported separately, pharma giant could be making the division's assets more visible to potential buyers. Its sales pitch: "With a strong portfolio of global brands that span health and wellness, the company believes this business is well positioned to continue its growth."
Bristol-Myers Squibb weighs selling its UPSA French OTC business, conducting a strategic review to assess its growth potential. Milan-based Recordati, says it plans to grow its OTC business; the firm sold a 51.8% stake owned by the Recordati family to a consortium of private equity funds for $3.56bn.
UK's advertising regulator agrees that P&G's TV ads for Oral B Gum and Enamel Repair toothpaste were misleading. P&G argued ad claims that the product could fix enamel and reverse damage were cosmetic, not medicinal, because they only suggested the product could protect gums and promote overall oral health.
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