RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”

Agency safety communication says needle-free dermal filler “pens” sold OTC on social media could pose a serious risk to consumers. It's aware of serious injuries, including  permanent harm to skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.

A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.

Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.

FDA makes withdrawal effective on 31 December, also the deadline for firms manufacturing or compounding alcohol-based hand sanitizer products, and making alcohol for those products under temporary guidances, to cease production.

"Fewer people are manufacturing the products ... That seems to be a sort of a natural reaction to I think the decreased consumer demand," says Donald Ashley, compliance chief in FDA’s drug center.

The latest European consumer health business news: France's EA Pharma snaps up Spain's Drasanvi; Italy's Bios Line attracts minority investment; and Diapharm sets up in Switzerland to help device manufacturers.

OTC private label/store brand giant announces Irish authorities allow it to pay $308.7m to settle a $1.9bn assessment for back taxes ordered in 2018 linked to Rx ingredient royalty rights it gained in its 2103 merger with Elan.

UK R&D firm Futura Medical strikes third commercial agreement for its drug-free erectile dysfunction treatment MED3000, this time with Switzerland’s Labatec Pharma, which will take the drug-free gel to the Middle East. 

July-September sales of OTC drugs, supplements and personal care products will come with CEO leaving J&J and P&G, a new leader for Perrigo Americas, Bausch Health likely offering Bausch + Lomb separation details and a cloud of rising costs related to supplies.

RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”

Consumer Healthcare Products Association names Duffy MacKay as its first senior VP for dietary supplements. Former CRN executive moves from CV Sciences back into trade group world.

July-September sales of OTC drugs, supplements and personal care products will come with CEO leaving J&J and P&G, a new leader for Perrigo Americas, Bausch Health likely offering Bausch + Lomb separation details and a cloud of rising costs related to supplies.

Germany's PharmaSGP blamed ongoing lockdowns for falling first-half sales, but said it could see light at the end of the tunnel, with the OTC market expected to recover in the second half of the year.

Stada reported Branded Products sales up 9% in the first half as it secured two additions to its portfolio, with a US dietary supplement brand and Nordic herbal analgesic.

Consumers can contact Coppertone for refunds for aerosol sunscreens found to contain benzene, a human carcinogen that should not adversely affect users at levels detected, the Beiersdorf brand says. More cosmetics regulatory and legal news in brief.

OTC private label/store brand giant announces Irish authorities allow it to pay $308.7m to settle a $1.9bn assessment for back taxes ordered in 2018 linked to Rx ingredient royalty rights it gained in its 2103 merger with Elan.

HRA’s approval for pharmacy sales of a daily oral contraceptive the UK and its ongoing work on an NDA to propose making another progestin-only contraceptive ingredient available OTC in the US stand out as additions to Perrigo’s business with the most substantial revenue impacts.

Stada’s UK subsidiary Thornton & Ross has added a Night Cold & Flu Relief Oral Solution to its popular Care pharmacy brand.

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

UK consumer health-tech firm Clinova's Caidr self-care app now has a super-fast search engine that creates customised health content feeds and points users to OTC products. 

Viatris' marketing director Rob Elliott speaks to HBW Insight about how the company is investing in flagship OTC erectile dysfunction treatment Viagra Connect to ensure the brand keeps ahead of the growing competition. 

HBW Insight speaks to regulatory expert and TheScienceGrad founder Natasha Barrow about trust in self-care, and how consumer healthcare companies can become a 'source of truth' in a confusing and misleading world.

GSK Consumer Healthcare shows Corsodyl and Sensodyne some love with two big budget marketing campaigns in the UK. 

Agency safety communication says needle-free dermal filler “pens” sold OTC on social media could pose a serious risk to consumers. It's aware of serious injuries, including  permanent harm to skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.

Directly billing insurers for OTC hearing aids may have triggered federal concern, a financial analysis firm says.

At NAD conference, Commissioner Slaughter identified “erroneous points of conventional wisdom that tend to undergird legal and policy debate about digital surveillance,” starting with privacy being “the key issue” and including “the FTC is toothless, absent new federal legislation.”