Archive

Patient access to unapproved medical products allowed under DeFazio, Daschle bills.

 
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PATIENT ACCESS TO UNAPPROVED MEDICAL PRODUCTS WOULD BE ALLOWED under legislation introduced by Rep. Peter DeFazio (D-Ore.) on July 12 and Sen. Tom Daschle (D-S.D.) on July 14. Called the Access to Medical Treatment Act, the legislation would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements to patients as long as there is no evidence the treatment causes harm and the patient is informed about the treatment and its possible side effects. DeFazio's bill is identified as HR 2019; Daschle's version will be assigned a bill number the week of July 17.

ADHD Medications and Cardiovascular Effects: New Data Revealed. (A Comprehensive Evaluation of Emerging Clinical and Epidemiological Evidence on the Cardiovascular Effects Associated with Commonly Prescribed Medications for Attention Deficit Hyperactivity Disorder)

 
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A look at new research on the cardiovascular effects of ADHD medications and what it means for clinical care. This article explores the latest clinical and epidemiological research on the cardiovascular effects of medications commonly prescribed for ADHD, examining potential heart-related risks, underlying mechanisms, and their implications for patient safety, clinical decision-making, and long-term treatment strategies across diverse age groups and risk profiles.

Neutrogena Enters ‘Pre-Aging’ Skin, Pushes Collagen Bank To Gen Z

 

Neutrogena Collagen Bank contains patented micro-peptide technology two times smaller than leading anti-aging peptides on the market to penetrate more than 10 layers under the surface of skin, says Kenvue, Inc. The product duo marks the brand’s entry into the ‘pre-aging’ segment.


‘Industry Not Ready’: MoCRA Could Spell Adverse-Event Reporting Whiplash

 

Jaclyn Bellomo, senior director of cosmetics science and regulatory affairs for Registrar Corp, cautions that MoCRA’s new requirements for adverse event reporting could strain industry systems if they aren’t adequately prepared.

TEST - U.S. Certifier QAI, NaTrue Mutually Recognize Products With Organic Content U.S. Certifier QAI, NaTrue Mutually Recognize Products With Organic Content

 
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Products certified in the U.S. as containing organic ingredients will be eligible for expedited certification across the Atlantic under a mutual recognition agreement between San Diego, Calif.-based Quality Assurance International and Brussels-based industry group NaTrue

TEST - FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers

 
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The MI/MCI preservative combination is a suspect being explored by FDA as part of its investigation into reports of hair loss and other adverse effects linked to WEN Cleansing Conditioners. The agency discusses testing it undertook to quantitate the WEN products’ MI/MCI content in a response to concerns raised by Democratic Congressman Frank Pallone of New Jersey.

TEST - Files Upload powerup - Food Import Prior Notice Content Requirements Should Be Abridged – GMA

 
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Only three data elements critical to identifying an article of food or dietary supplement should be required by FDA in prior import notices, the Grocery Manufacturers of America states in April 4 comments


Over The Counter: Why Purpose Is Key To Driving CHC Growth, With Haleon’s Bas Vorsteveld

 
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In this episode of Over the Counter, HBW Insight catches up with Haleon vice president and general manager Great Britain and Ireland, Bas Vorsteveld, to find out about why having a purpose is so important to establishing and growing a global consumer health brand.

US FDA Funds Study To Learn Whether Kratom Users Have ‘Any Risk/Safety Considerations’

 

Agency says study “intended as a strategic response to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” Objectives include understanding temporal relationships and correlation of purchase decisions and how marketing strategies nudge purchase and affect use demand.

Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports

 

Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products globally, transmits information to internal stakeholders and formats serious events to the FDA Medwatch format for submission.

Debut ‘Democratizes’ Biotech Product Formulation, Promising Superior Claims, Sustainability

 

San Diego-based Debut Biotechnology, Inc., which recently expanded an ingredient development partnership with L’Oréal SA, has launched BiotechXBeautyLabs development and contract manufacturing to make it possible for all brands – even those without expertise, proprietary ingredients or investment capability – to join the biotech revolution.


Stada Strikes Deal To Expand Middle East And Africa OTC Portfolio

 
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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.

J&J Agrees To Pay $700M To Settle Talc Claims With 43 State AGs

 

Johnson & Johnson has agreed to settle with 43 state attorneys general over products that previously contained talc, planning to pay $700m in four payments through 2027. The settlement is not an admission of guilt, and J&J stands by the safety of the products in question, which it no longer markets with talc.

Over The Counter: Leading PRO Discusses Plans For Administering State EPR Programs

 

In this episode, HBW chats with John Hite of leading producer responsibility organization Circular Action Alliance, which is administering extended producer responsibility (EPR) programs under new laws entering into force in three states next year. With a 1 July deadline to register with CAA, Hite discusses steps companies should take now, how his organization will assist producers and estimates for collecting fees.

L’Oreal Most Valuable Brand On Globe, Natura ‘Strongest’ – Brand Finance

 

L’Oreal’s SA is again the most valuable beauty brand globally as measured by brand-valuation consultancy Brand Finance plc. Meanwhile, Garnier is fastest-growing, and Natura is strongest based on consumer sentiment and other factors, the firm says.


Celebrity Beauty Revenues Soar 58% In 2023, With Rihanna Reigning Again

 

Fenty Beauty by Rihanna was again the leading celebrity beauty brand in 2023, generating sales of $602.4m globally, followed by the hair-care line of Priyanka Chopra Jonas and cosmetics by Kylie Jenner.

Tylenol Label Warning Complaint Dismissed With Judge's Federal Preemption Question Unanswered

 

Marketers of other drugs available under FDA OTC monograph should note dismissal of complaint against Kenvue didn’t resolve the judge’s questions about whether federal preemption precludes challenges to safety and labeling.

In Proposed Appropriation, Congress Tells FDA To Repurpose $7M For Cosmetic Regulation

 

Proposed budget agreement by House and Senate leaders comes four days before funding ends under the latest continuing resolution to keep the federal government open and a week before the White House plans to release its FY2025 budget request.

Publisher’s Spotlight: Citeline News And Insights App

 
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Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.