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Regulation/Legislation (Health)

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Regulation

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Latest From Health & Regulation

First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

OTC Drugs Guidance Documents

US Consumer Health Q2 Earnings Preview: If Not For Headwinds, Tailwinds Would Be Trending

Analysts tracking consumer health product firms in the US anticipatevApril-June results lower than a year ago across most businesses. While some results will be lower on comparisons with strong growth in 2023, others will reflect a slow allergy season, retailers’ inventories remaining high as consumer spending slows or firms continuing to recover from supply chain problems.

Consumer Business Strategies

Chevron Deference Muted, Higher Volume Ahead For US Supplement Market Regulatory Questions

Attorneys discuss potential impacts on consumer health products industry from Supreme Court’s “Loper Bright” decision in June on litigation brought by two fisheries, Loper Bright v. Raimondo and Relentless v. Department of Commerce.

FDA Litigation
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

OTC Drugs Guidance Documents

PAGB: Labour Must Prioritize Self-Care In First 100 Days Of New UK Government

The UK's consumer healthcare industry association, PAGB, sets out six priorities for the new UK government, following the landslide victory of the Labour Party in the recent general election. One of these priorities is driving Rx-to-OTC switch - something that the UK public also wants, according to the association's latest Self-Care Census, published to mark International Self-Care Day 2024.

United Kingdom Health

Pandemic Emergency OTC Sanitizer Makers Have 22 Weeks To Avoid Paying Monograph User Fees

FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.

Coronavirus COVID-19 User Fees
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