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Health (OTC Drugs)

Set Alert for Health (OTC Drugs)

Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

IND Warning Has US Supplement Firm ISO Answers

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.”

Warning Letters Dietary Supplements

US FDA Warns Of Safety Risk OTC Needle-Free Devices Used For Dermal Fillers

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.

FDA OTC Devices

Real-World Evidence Can Play Important Role In OTC Regulation – AESGP Study

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.

Real-World Evidence OTC Drugs

US OTC Monograph FY2022 Facility Fees Deadline In June At Amount TBD

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

User Fees OTC Drugs

US FDA Plans Year-End Rinse Of Temporary Policy Easing Standards For OTC Sanitizer Production

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.

Coronavirus COVID-19 Guidance Documents

OTC Sanitizer Contaminations Drop In US As Auxiliary Manufacturers Stop 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.

Coronavirus COVID-19 OTC Drugs
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Business Explore this Topic

Set Alert for Business {Health}

Latest From Deals & Health

EU Business Round-Up: EA Pharma Acquires Drasanvi, Bios Line Attracts Investment, Diapharm Sets Up Swiss Office

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.

Europe Health

Perrigo Paying $309M To Settle $1.9Bn Irish Tax Assessment From Elan Merger

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.

M & A Legal Issues

Futura Strikes Deal To Commercialize Erectile Dysfunction Gel In Middle East

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. 

Middle East and Africa Jordan
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Latest From Business Strategies & Health

US Q3 Consumer Health Earnings Preview: Helm Changes, Supply Challenges, Separation Plan

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.

Sales & Earnings Consumer

IND Warning Has US Supplement Firm ISO Answers

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.”

Warning Letters Dietary Supplements

Naturopath, Regulatory Expert MacKay Returns To DC As CHPA’s Supplement Industry Strategy Chief

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.

Dietary Supplements Lobbying
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Latest From Sales & Earnings & Health

US Q3 Consumer Health Earnings Preview: Helm Changes, Supply Challenges, Separation Plan

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.

Sales & Earnings Consumer

Germany’s PharmaSGP Predicts Market Turnaround Despite Difficult First Half

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.

Sales & Earnings Germany

Stada Expands Portfolio In US And Nordics As First-Half Sales Rise

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.

Deals Sales & Earnings
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Latest From Legal Issues & Health

Coppertone Recalls Benzene-Tainted Sunscreens; Cosmetics Regulatory & Legal News

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.

United States Cosmetic Ingredients

Perrigo Paying $309M To Settle $1.9Bn Irish Tax Assessment From Elan Merger

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.

M & A Legal Issues

Perrigo Continues Overhaul Adding HRA Pharma, Boosts Chances For OTC Oral Contraceptive In US

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.

M & A OTC Drugs
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Marketing Explore this Topic

Set Alert for Marketing {Health}

Latest From Launches & Health

Thornton & Ross Extends UK Care Line With Night-Time Cold & Flu Syrup

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

United Kingdom Health

Health And Wellness Weekly Trademark Review 12 October, 2021

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

Dietary Supplements OTC Drugs

Clinova’s Caidr Self-Care App Gets Super-Fast Health Search Update

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. 

United Kingdom Health
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Latest From Ad Campaigns & Health

Viatris Welcomes ‘Healthy Competition’ For UK OTC Erectile Dysfunction Top Spot

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. 

United Kingdom Health

Over The Counter, 20 Sept 2021: Being A Self-Care 'Source Of Truth' With TheScienceGrad's Natasha Barrow

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.

International Health

GSK Smiles On Corsodyl And Sensodyne Oral Care Brands With Big Budget UK Campaigns

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

United Kingdom Health
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Latest From Ad Complaints & Health

US FDA Warns Of Safety Risk OTC Needle-Free Devices Used For Dermal Fillers

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.

FDA OTC Devices

OTC Hearing Aid Firm Eargo Hears From US DOJ About Insurance Reimbursement Claims

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

Enforcement OTC Devices

Protecting US Consumer Data Just The Tip Of Online Privacy Iceberg, Says FTC’s Slaughter

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.”

Ad Complaints Enforcement
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