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Consumer Drugs

Set Alert for Consumer Drugs

OTC Monograph Application Reviews Get Deadlines, Not GRASE Flexibility

Changes to FDA's interpretation of the GRASE standard it uses to evaluate ingredient proposals would go further to opening the US monograph process to innovation and progress than setting deadlines for the reviews, industry stakeholders say.

Consumer Drug Approval Standards Regulation
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UK Nail Fungus 'Acts Fast' Claim Survives On Late-Emerging Evidence

UK agency says Vemedia Export supported Excilor nail fungus treatment claims with evidence including a study with more than 100 subjects that became available after Bayer challenged the Dutch firm's online advertising.

Consumer Advertising, Marketing & Sales

Sunscreen Industry Asks FDA For Flexibility Despite Guidances' Rigidity

FDA latest sunscreen guidances incorporate little industry input and are met with frustration and hope among industry stakeholders. The PASS Coalition and the Natural Products Association weigh in on future cooperation between FDA and industry under SIA.

United States Consumer

FDA Sunscreen Guidance: Absorption Data Is A MUsT For GRASE Review

The agency maintains maximal usage trials are essential in sunscreen ingredient GRASE assessments, despite industry objections that the tests have not been used for UV filters and no protocol is established. FDA’s final guidance closely mirrors its draft issued a year ago, which stakeholders projected would further delay consumer access to updated sunscreen products.

United States Consumer

Year-Round Vicks Advertising Part of P&G's Greater Reach Strategy

P&G’s Vicks brand will advertise year round since 40% of colds hit during times other than winter, P&G Chief Brand Officer Marc Pritchard says. The strategy also is part of the firm’s push to grow media reach for certain brands by as much as 20%.

Consumer Advertising, Marketing & Sales

Nonprescription Nasonex Gains UK Regulator’s Support

The UK MHRA is accepting comments on its recommendation to allow pharmacy sales of nonprescription Nasonex Allergy Control (mometasone furoate/100 mcg).

Consumer Prescription To Otc Switch

Consumer Health Products Weekly Trademark Review Nov. 15, 2016

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

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