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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diversity & Inclusion Clinical Trials

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline. 

Diversity & Inclusion Clinical Trials

Pharmacy ‘P’ Medicines Now Available For Self-Selection In The UK

Good news for manufacturers selling Pharmacy "P" medicines in the UK - they will soon be able to market many of these products for self-selection in pharmacies, thanks to a surprise change by the regulator the UK General Pharmaceutical Council.

United Kingdom Health

AESGP Publishes Guidance For EU Companies Advertising Self-Care Products Online

When it comes to online consumer health product advertising, complying with regulations, ensuring that content is factually correct and being transparent are some of the key principles that companies should adhere to, recommends AESGP in a recently published position paper. 

Europe Health

EU Green Claims Directive: Council Wants Lighter Touch, Especially For SMEs

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

Europe Health
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Business Explore this Topic

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Latest From Deals & Health

Stada Strikes Deal To Expand Middle East And Africa OTC Portfolio

A deal between Stada Arzneimittel and Adcan Pharma will see the former exclusively market and commercialize in the UAE a portfolio of 15 consumer healthcare products produced and supplied by the latter.

Middle East and Africa United Arab Emirates

US Wellness Market Movers: Doctor’s Best, Society Brands, CharmHealth

Doctor's Best acquires Viactiv calcium and magnesium brand from Guardion; VitaliyNow is Society Brands’ third 2024 acquisition; and VitaminLab formulation services on CharmHealth.

Dietary Supplements Deals

Spain's Uriach Expands In Europe With Pascoe And Ineldéa

Consumer health manufacturer Uriach has agreed to acquire Germany's Pascoe Naturmedizin and through a separate transaction France's Laboratoires Ineldéa, following investment by private-equity firm ICG.

Europe France
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Latest From Business Strategies & Health

Stada Strikes Deal To Expand Middle East And Africa OTC Portfolio

A deal between Stada Arzneimittel and Adcan Pharma will see the former exclusively market and commercialize in the UAE a portfolio of 15 consumer healthcare products produced and supplied by the latter.

Middle East and Africa United Arab Emirates

Over The Counter: How To Innovate For The Ages, With Bayer’s Reese Fitzpatrick And Rachel Koontz

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

Europe International

Talc Litigation Attorneys Allege ‘Bad Faith Filings,’ ‘Fraudulent Activities’ By J&J In Bankruptcy

Attorneys for some plaintiffs alleging harm from talc products J&J marketed ask a court to order the firm, along with a subsidiary holding company it created in 2021 to manage its talc liabilities and immediately placed in bankruptcy, to provide emails and other communications among in-house counsel and compel their testimony.

Cosmetics OTC Drugs
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Latest From Sales & Earnings & Health

Alliance Pharma Books £46m Impairment Charge Related To US Menopause Supplement

Alliance Pharma has been hit by a non-cash impairment charge of £46.4m related to its Amberen dietary supplement reflecting the brand's struggles in the US e-commerce market.

Sales & Earnings Dietary Supplements

Marketplace Shows Consumers Bouncing Off Gummy Form Vitamins, Church & Dwight Sees

More than a decade after acquiring vitafusion and L’il Critter gummy vitamin brands and touting gummy as a key growth driver in the VMS space, C&D’s seeing different market trends.

Dietary Supplements Retail

Clear Eyes Production Problems Prestige Consumer Didn’t See Coming Leave Supply On Shelves ‘Spotty’

“Clear Eyes is a perfect example where we're dual-sourced and two facilities don't usually go down at the same time. This was just a quite an anomaly,” says CFO Christine Sacco, noting PCH works with more than 100 contract manufacturers.

OTC Drugs Supply Chain
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Latest From Legal Issues & Health

Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA

Supreme Court Mifepristone Decision Sets High Bar For FDA Suits, But Risks To Agency Authority Linger

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

Women's Health Litigation

NAD Oddball: Thermometer Case Administratively Closed As Advertiser Takes Matter To Federal Court

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

Advertising, Marketing & Sales Legal Issues
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Marketing Explore this Topic

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Latest From Launches & Health

Stada Strikes Deal To Expand Middle East And Africa OTC Portfolio

A deal between Stada Arzneimittel and Adcan Pharma will see the former exclusively market and commercialize in the UAE a portfolio of 15 consumer healthcare products produced and supplied by the latter.

Middle East and Africa United Arab Emirates

US Wellness Market Movers: Doctor’s Best, Society Brands, CharmHealth

Doctor's Best acquires Viactiv calcium and magnesium brand from Guardion; VitaliyNow is Society Brands’ third 2024 acquisition; and VitaminLab formulation services on CharmHealth.

Dietary Supplements Deals

Futura's Eroxon Reaches 10 Countries In First Half Of 2024

France, Italy and Spain among the 10 countries where Futura Medical has rolled out its Eroxon drug-free erectile dysfunction treatment in the opening six months of the year.

Europe Launches
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Latest From Ad Campaigns & Health

AESGP Publishes Guidance For EU Companies Advertising Self-Care Products Online

When it comes to online consumer health product advertising, complying with regulations, ensuring that content is factually correct and being transparent are some of the key principles that companies should adhere to, recommends AESGP in a recently published position paper. 

Europe Health

EU Green Claims Directive: Council Wants Lighter Touch, Especially For SMEs

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

Europe Health

UK Medical Device Firm Owen Mumford Launches Pelvic Health Consumer Brand

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

Europe United Kingdom
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Latest From Ad Complaints & Health

EU Green Claims Directive: Council Wants Lighter Touch, Especially For SMEs

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

Europe Health

ASA Files: Denigrating Competitors ‘Isn’t A Good Look’ For Advertisers

Bayer Consumer Health and its effervescent vitamin brand Berocca were subjects of denigratory remarks by an online competitor in a recent UK advertising complaint ruling. The ASA’s Freddie Alcock talks HBW Insight through the complaint, explaining in this exclusive interview why denigration is never a good look for advertisers.

United Kingdom Health

ASA Files: It’s Not Just What You Say, But How You Say It

Infirst has been admonished by UK ad authority, ASA, for implying in a TV commercial its lipid-based ibuprofen brand Flarin was more, or uniquely, effective for joint pain relief than other forms of ibuprofen.

United Kingdom Health
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