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Consumer Drugs

Set Alert for Consumer Drugs

Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn

OTC proton pump inhibitors should carry a warning that the products do not eliminate risks of esophageal cancer from persistent heartburn, says the Esophageal Cancer Action Network in a citizen petition to US FDA. FDA should “immediately” require the warning, which should be bold and prominent.

Consumer Drug Safety Regulation
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Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

Consumer Legislation

OTC Topicals Firm's Regulatory Problems More Than Skin Deep

FDA's warning letter submitted following an October 2016 at Phillips Co.'s Millerton, Okla., facility states that the company does not appear committed to correcting the GMP, labeling and branding problems Office of Regulatory Affairs officials found.

Consumer Manufacturing

Consumer Health Weekly Trademark Review May 9, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

China India

FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap

CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when new approaches might help enable FDA to propose regulatory changes in the US switch process.

Prescription To Otc Switch Consumer

Smartphone Apps Appropriate For OTC Product Instructions – Consultant

“The present has passed us by” in using appropriate technology to provide consumers more information than on US Drug Facts labels, Pinney Associates’ Saul Shiffman says at CPHA conference.

Consumer Drug Safety

Codeine Concerns Cough Up FDA's OTC Monograph Problems

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

Consumer Drug Safety

Consumer Health Weekly Trademark Review May 2, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled by from the Official Gazette of the U.S. Patent and Trademark Office.

India Indonesia

'Do Not Flush' Labels For Acne, Hemorrhoid Wipes Won't Stop Consumers – CHPA

Consumer products group hopes a Washington, D.C., mandate for "do not flush labeling on nonwoven disposable wipes" beginning in 2018 does not create momentum for similar rules in Maryland, New York, New Jersey, Minnesota and in New York City.

United States Consumer

Navigating Amazon: E-Commerce Giant Critical For OTC Drug Sales

As Amazon emerges as the leading search engine for information about consumer packaged goods products, OTC drug and other consumer health product firms should establish a presence, even if they expect not to sell much, says BeeKeeper consultancy's Lynn Graham.

Consumer Advertising, Marketing & Sales

Returns From Sanofi Consumer Expansion Could Point To More

The French pharma's strategy of driving consumer health business growth by expanding the product lineup played out during the first quarter with the launch of OTC switch Xyzal Allergy and with further integration of OTC drug and vitamin brands recently acquired from Boehringer Ingelheim.

Consumer Advertising, Marketing & Sales
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