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Regulation/Legislation (Health)

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Regulation

Set Alert for Regulation {Health}

Latest From Health & Regulation

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

Ad Complaints Consumer

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

Europe Health

US FDA Electronic Drug Registrations Key For OTC Monograph Fees Plus Keeping Tabs On Products

FDA drug user fee program chief tells OTC industry stakeholders accurate information in electronic Drug Registration and Listing System is key to setting annual facility registration user fee rates. CDER publishes warning letters to US retailer and a South Korean manufacturer noting noncompliance with eDRLS requirements.

Warning Letters OTC Drugs
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

Europe Health

OTC Monograph FY2024 Proposal Fees Published As FDA Anticipates Change Requests Starting

“The agency anticipates a greater likelihood of OMOR submissions compared to prior fiscal years,” CDER says. In fourth year of initial five-year authorization of OMUFA, FDA getting ready to receive OMOR submissions from drug firms and other industry stakeholders.

FDA OTC Drugs

US Advisory Panel Leaves No Room For Doubt: Oral Phenylephrine Ineffective As Nasal Decongestant

Action on unanimous statement by Nonprescription Drug Advisory Committee could be one of FDA’s first in its more streamlined process for making OTC monograph changes. Regulatory change on phenylephrine available in US also could reach OTC and Rx drugs available through applications.

Advisory Committees OTC Drugs
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